Biopsy Port Cleaning Adapter

GUDID 14897106957818

GA Health Company Limited

Surgical instrument/endoscope cleaning utensil, single-use
Primary Device ID14897106957818
NIH Device Record Keya929f2a3-34a8-42bf-9837-e1da80750be7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopsy Port Cleaning Adapter
Version Model NumberGAR075-S
Company DUNS686908512
Company NameGA Health Company Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104897106957811 [Primary]
GS114897106957818 [Package]
Contains: 04897106957811
Package: box [50 Units]
In Commercial Distribution
GS124897106957815 [Package]
Package: carton [6 Units]
In Commercial Distribution

FDA Product Code

FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-12
Device Publish Date2025-08-04

Devices Manufactured by GA Health Company Limited

04897106957798 - Air/Water Channel Cleaning Adapter2025-08-12
14897106957801 - Air/Water Channel Cleaning Adapter2025-08-12
14897106957818 - Biopsy Port Cleaning Adapter2025-08-12
14897106957818 - Biopsy Port Cleaning Adapter2025-08-12
14897106957825 - Air/Water Channel Cleaning Adapter2025-08-12
14897106957078 - Air Water Channel Cleaning Adapter2025-08-08
14897106955258 - Protego Air Water Bottle Tubing 2025-08-07
14897106955333 - Protego Air Water Bottle Tubing with CO2 Extend 2025-08-07
14897106955494 - Protego Hybrid Tubing with CO2 Extend 2025-08-07

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.