Urinary Drainage Bag

GUDID 00616784427133

DYNAREX CORPORATION

Non-wearable urine collection bag, open-ended
Primary Device ID00616784427133
NIH Device Record Key58636004-3a13-4e9f-9948-34fbfa373f46
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrinary Drainage Bag
Version Model Number4271
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784427119 [Unit of Use]
GS100616784427133 [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 Number3
Public Version Date2019-12-11
Device Publish Date2016-09-24

On-Brand Devices [Urinary Drainage Bag]

006167844271334271
006167844270344270

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