18586021475335

Organization name

Sky Medical a.s.

SRN

SK-MF-000001475

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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• CW999

  For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors. It is highly recommended to consult the instructions before use

Primary placement in Slovakia; available across 1 country total.

Trade name

18586021475335

UDI-DI code

18586021475335

Basic UDI-DI

602147GBUTTON5G

Reference / catalog number

GH202510VE

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Low-Profile Gastrostomy Replacement Tube (G. Button) Kit with the main component being the G. Button. The G. Button is a silicone feeding device comprised of a body, two‑lumen shafts, and a retaining balloon. The G. Button body has two ports and a strap with a cap. The first port with a feeding ring and duckbill valve connected to the lumen for feeding and or medication. The second port with an inflation valve is connected to the lumen for balloon inflation. The device is translucent with an X-Ray line (silicone base with BaSO4 - Barium sulphate) for X-ray determination of the tube position in the patient body. The device is packed with accessories into a kit

Additional information URL

https://www.med-sky.com/

Clinical sizes

• 20 MU170
• 2.5 MU10

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• G02020201GASTROSTOMY, TUBES AND SETS