Disposable Four-Chamber Polyp Trap

GUDID 14897106955067

GA Health Company Limited

Surgical suction system collection container, single-use
Primary Device ID14897106955067
NIH Device Record Keye6a327fc-e445-43b3-825c-4d18edea24aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Four-Chamber Polyp Trap
Version Model NumberEN10103.4
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104897106955060 [Primary]
GS114897106955067 [Package]
Contains: 04897106955060
Package: Box [12 Units]
In Commercial Distribution
GS124897106955064 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

CBCBottle, Collection And Trap, Breathing System (Uncalibrated)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

Devices Manufactured by GA Health Company Limited

14897106955531 - andorate® Champion 3-piece valve kit2024-10-17
04897106953363 - andorate® 2-piece Valve Kit2024-10-14
14897106954626 - andorate® Suction Valve2024-10-14
14897106955166 - andorate® Biopsy Valve2024-10-14
14897106955562 - andorate® Champion 4-piece valve kit2024-10-14
14897106955579 - andorate® Champion 3-piece valve kit2024-10-14
14897106955616 - andorate® Champion 3-piece valve kit2024-10-14
14897106955647 - andorate® Champion 4-piece valve kit2024-10-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.