AWI

GUDID 16972130470460

Disposable Irrigation Bag(Apply to Extremity)

Apex (Suzhou) Medical Products Company

Closed-wound/centesis drainage receptacle
Primary Device ID16972130470460
NIH Device Record Key0a65835e-9392-42bf-9829-8ebba1db590c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAWI
Version Model Number210-05
Company DUNS554507451
Company NameApex (Suzhou) Medical Products Company
Device Count40
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
GS106972130470463 [Primary]
GS116972130470460 [Unit of Use]
GS126972130470467 [Primary]

FDA Product Code

FONBag, Drainage, With Adhesive, Ostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-14
Device Publish Date2020-12-04

On-Brand Devices [AWI]

26972130470436Disposable Pulse Irrigation Kit
06972130470418Hydra Adaptor
06972130470401Tunnel Tip
06972130470395Disposable Irrigation Bag(Apply to Trunk-L)
06972130470388Disposable Irrigation Bag(Apply to Extremity)
16972130470439Disposable Pulse Irrigation Kit
16972130470422Standard Tip
06972130470432Disposable Pulse Irrigation Kit
06972130470425Standard Tip
26972130470511Disposable Pulse Irrigation Kit
06972130470517Disposable Pulse Irrigation Kit
06972130470500Standard Tip
16972130470507Standard Tip
16972130470491Hydra Adaptor
16972130470484Tunnel Tip
16972130470477Disposable Irrigation Bag(Apply to Trunk-L)
16972130470460Disposable Irrigation Bag(Apply to Extremity)
16972130470514Disposable Pulse Irrigation Kit
26972130470535Disposable Pulse Irrigation Kit
16972130470538Disposable Pulse Irrigation Kit
06972130470531Disposable Pulse Irrigation Kit

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