Nama Produk Rocket® Seldinger Chest Drainage Kit 18 Fg

Merk Rocket

No. Produk Penyedia 18 Fg

Unit Pengukuran Dus

Kategori Peralatan Rumah Sakit Umum dan Perorangan

Sub Kategori Peralatan Rumah Sakit Umum dan Perorangan Lainnya

Jenis Produk Vacuum-powered body fluid suction apparatus.

Kode KBKI 4815000047

Berlaku Sampai 8 Februari 2021

Model/Type 18 Fg

Country of Origin United Kingdom

Factory of Origin United Kingdom

Product Certification ISO 13485

Product Registration (AKD/AKL/Lainnya) AKL 20903715183

CE Mark CE 0088

Where Marketed United States, Australia, Canada, Eropa, Singapura, Malaysia, Indonesia

Other Specification

Rocket® Seldinger Chest Drainage Kit 18 Fg terdiri dari:

1 x Skin knife/ Scalpel

1 x Introducer

1 x Guide wire

1 x 10cm dilator(s)

1x Coaxial chest tube inserter and Clear drainage 18 Fg catheter with radiopaque

stripe

1 x 10ml Syringe

1 x Fir tree connector

1 x Wide bore luer connector

1 x Stopcock/ Wide bore 3 way tap

Function

Rocket Seldinger Chest Drainage Kit 18 Fg digunakan untuk penyisipan percutaneous

dari drainase pleura cairan ataupun udara dan sangat cocok untuk:

- Pneumotoraks spontan atau iatrogenik

- Efusi jinak ataupun ganas, kecuali efusi yang mengandung protein tinggi

- Empiema viskositas rendah

Keterangan Lainnya

a. Produk ini sterile

b. Produk ini ditujukan untuk penggunaan sekali pakai

c. Diproduksi oleh Rocket Medical PLC, United Kingdom

d. Ukuran kemasan 180x410mm

e. dus isi 1 kit

Gambar

Spesifikasi Produk Rocket® Seldinger Chest Drainage Kit 18 Fg

KEMENTERIAN KESEHATAN REPUBLIK INDONESIA DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950Telepon : (021) 5201590 Pesawat 2029, 8011Faksimile : (021) 52964838 Kotak Pos : 203

Catatan: - UU ITE No 11 Tahun 2007 Pasal 5 ayat 1 Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikanpersetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

A L A T K E S E H A T A N

KEMENKES RI AKL 20903715183

Nama Dagang / Merek : ROCKET® Seldinger Chest Drainage Kit

Kelompok / Kelas Resiko : Non Elektromedik Steril / B

Kategori Produk : Peralatan Rumah Sakit Umum dan Perorangan

Sub Kategori : Peralatan Rumah Sakit Umum dan Perorangan Lainnya

Jenis Produk : Vacuum-powered body fluid suction apparatus.

Tipe / Ukuran : 12Fg, 18Fg

Kemasan : Dus isi 1 dan 10 pcs

Nama Produsen / Pabrikan : ROCKET MEDICAL PLC., United Kingdom

Nama Pendaftar : PT. SOMNOTEC INDONESIA, DKI Jakarta

Atas dasar lisensi dari : -

Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 08 Februari 2021.

2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat

penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.

3. Izin edar ini merupakan persetujuan perpanjangan dan perubahan aksesoris dari Nomor Izin Edar

Alat Kesehatan KEMENKES RI AKL 20903715183 tanggal 22 September 2017. Dengan

demikian izin edar sebelumnya dinyatakan tidak berlaku.

4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk

tersebut, pendaftar bersedia mengembalikan izin edar.

5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari

persetujuan izin edar ini.

6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau

kembali.

Jakarta, 02 April 2019

KEMENTERIAN KESEHATAN REPUBLIK INDONESIA DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950Telepon : (021) 5201590 Pesawat 2029, 8011Faksimile : (021) 52964838 Kotak Pos : 203

Catatan: - UU ITE No 11 Tahun 2007 Pasal 5 ayat 1 Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

LAMPIRAN NOMOR IZIN EDAR

ALAT KESEHATANKEMENKES RI AKL 20903715183

No. Deskripsi Tipe / Kode

1 Rocket Seldinger Chest Drainage Set with Safety Guards R54544-12-SG

2 Rocket Seldinger Chest Drainage Set with Safety Guards R54544-18-SG

3 Rocket Seldinger Chest Drainage Tray Complete Ward ProcedureSet

R54544-12-PK

4 Rocket Seldinger Chest Drainage Tray Complete Ward ProcedureSet

R54544-18-PK

5 Rocket Seldinger Chest Drainage Training DVD R54544-DVD

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yangtercantum dalam lampiran ini

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Jakarta, 02 April 2019

The Rocket® Seldinger Chest Drainage Set is indicated for the percutaneous insertion of a pleural drain for fluid and air and is particularly suitable for: 1

Pneumothorax, spontaneous or

iatrogenic

Effusions, benign or malignant,

except those with high protein content.

Low viscosity empyema

The Rocket® Seldinger Chest

Drainage Set features:

Improved patient comfort using

small bore catheterisation 2,3

Reliable insertion via Seldinger

approach under direct vision, x-ray screening or ultrasound guidance

10cm dilators with safety stops to

minimise the risks of over-insertion associated with the traditional 20cm dilator.

Drapes and a gown are included

in all PK coded packs in response to NPSA/2008/RRR3

References:

1. Clinical Evaluation of Seldinger Drainage Kit. Beaumont A C et al Proceedings of Intensive Care Society Meeting. December 1999.

2. Catheters smaller than 24 French gauge can

be used for chest drains. Taylor PM. BMJ (1997) 315:186

3. Management of Malignant Pleural Effusions Antunes G, Neville E,Thorax (2000) 55:981-983

Description Size Code

Rocket® Seldinger Chest Drainage Set

with Safety Guards Skin knife, echogenic tipped insertion needle, guidewire, 10cm dilators with Safety Guards, 30cm catheter with radiopaque stripe and tip, syringe, stopcock, fir-tree & wide-bore luer connectors. Sterile, single use in cartons of 5 units.

12FG R54544-12-SG

18FG R54544-18-SG

Rocket® Seldinger Chest Drainage Tray

Complete Ward Procedure Set Skin knife, echogenic tipped insertion needle, guidewire, 10cm dilators with Safety Guards, 30cm catheter with radiopaque stripe and tip, syringe, stopcock, fir-tree & wide-bore luer connectors, skin fixation set, ward procedure pack including drapes, swabs, sponges, 10ml syringes, gallipot. Sterile, for single use in cartons of 5 units.

12FG R54544-12-PK

16FG R54549-16-PK

18FG R54544-18-PK

20FG R54544-20-PK

Rocket® Seldinger Chest Drainage Training DVD

A clinician’s guide to the safe insertion and connection of Rocket® Seldinger Chest Drainage Sets

R54544-DVD

Rocket® Seldinger Chest Drainage Sets

Rocket Medical plc

Sedling Road. WASHINGTON, Tyne & Wear, NE38 9BZ

T: +44 (0) 191 419 6988 E: customerservices@rocketmedical.com W: www.rocketmedical.com

Rev: 07 Date: 2016-05-04

Copyright© 2014-16

ROCKET MEDICAL PLC SEDLING ROAD WASHINGTON TYNE & WEAR NE38 9BZ ENGLAND

TEL: +44 191 419 4488

FAX: +44 191 419 5693

Email: customerservices@rocketmedical.com

www.rocketmedical.com

REGISTERED OFFICE REGISTERED IN ENGLAND IMPERIAL WAY NO. 03276608 WATFORD WD24 4XX

22nd October, 2020

STATEMENT LETTER

OF KIT COMPONENTS ROCKET PRODUCT

Dear Sir/Madam,

We are Rocket Medical plc, Sedling Road, Washington, Tyne and Wear, NE38 9BZ, UK, a company established

pursuant to the laws of United Kingdom with registration no. 3726608, hereby state that the brochure and table

of Kit Components Rocket product together with this letter are valid. For the following product:

R54400-16-MT R54400-MINI R54544-12-00 R54544-18-00 R54564

Rocket IPC Insertion

16 FG metal

tunneller

Rocket IPC Mini

Insertion 16 FG

Rocket Seldinger

Chest Drainage Kit

12Fg

Rocket Seldinger

Chest Drainage Kit

18Fg

Rocket Ambulatory

Chest Drain, 500

ml 1 way valve bag

drainable

1 x Silicone Catheter

(16Fg) with metal

introducer

1 x Drainage line

1 x Valve cap

1 x Tunnelling forcep

and Scissors

1 x Foam Catheter Pad

1 x Clear-film dressing

1 x 18G guidewire

insertion needle

1 x J-Tip guidewire

1 x 16 Fr tearaway

sheath/dilator

1 x 10ml Syringe

1 x 1pr gloves (non-

latex)

1 x Safety scalpel

1 x 12ml Syringe

1 x Fenestrated drape

2 x Square drape

2 x Safety green needle

1 x Safety orange needle

8 x Gauze pads

1 x NeedleVise sharps

safety device

1 x Needle driver

1 x Gallipot

2 x Sponge swabs

1 x Stylet

1 x Silicone Catheter

(16Fg) with metal

introducer

1 x Drainage line

1 x Valve cap / Blue

safety clamp

1 x Tunnelling forceps

1 x Foam Catheter Pad

1 x Clear-film dressing

1 x 18G guidewire

insertion needle

1 x J-Tip guidewire

1 x 16 Fr tearaway

sheath/dilator

1 x 10ml Syringe

1 x Skin knife/ Scalpel

1 x Introducer needle

1 x Guide wire

1 x 10cm dilator(s)

1x Coaxial chest tube

inserter and Clear

drainage 12 Fg

catheter with

radiopaque stripe

1 x 10ml Syringe

1 x Fir tree connector

1 x Wide bore luer

connector

1 x Stopcock/ Wide

bore 3 way tap

1 x Skin knife/ Scalpel

1 x Introducer needle

1 x Guide wire

1 x 10cm dilator(s)

1x Coaxial chest tube

inserter and Clear

drainage 18 Fg

catheter with

radiopaque stripe

1 x 10ml Syringe

1 x Fir tree connector

1 x Wide bore luer

connector

1 x Stopcock/ Wide

bore 3 way tap

1x Integral vent discs

1x Activated carbon

filter

1x External valve and

empty valve

1x Flutter valve

1x Fir tree barb

connector

1x Belt/shoulder strap

1x Priming syringe

1x Over night bag

Connection

Sincerely yours,

Name: Tracy Charlton

Regulatory Affairs Manager