Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs

GUDID 00616784429038

DYNAREX CORPORATION

Wearable urine collection bag, open-ended
Primary Device ID00616784429038
NIH Device Record Key283c4229-293b-44f6-9506-5ca37807dd27
Commercial Distribution StatusIn Commercial Distribution
Brand NameBag, Urine Collection, Leg, for External Use, Sterile, 20/Cs
Version Model Number4290
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count20
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784429014 [Unit of Use]
GS100616784429038 [Primary]

FDA Product Code

KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-09-13

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