U-Bag Urine Collector

GUDID 00840113231706

Stork U-Bag, Urine Collection Bag, 200mL, Pediatric, Single Specimen, Cloth Adhesive, Sterile, 1/pouch, 100 pouches/box

ASPEN SURGICAL PRODUCTS, INC.

Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended Adhesive paediatric urine collection bag, closed-ended
Primary Device ID00840113231706
NIH Device Record Key1c15c0e2-df1b-4a06-bd16-b6c215908eeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Bag Urine Collector
Version Model Number7531
Company DUNS027680821
Company NameASPEN SURGICAL PRODUCTS, INC.
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 Datetrue
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
GS100840113231706 [Primary]

FDA Product Code

FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-07
Device Publish Date2023-02-27

On-Brand Devices [U-Bag Urine Collector]

00840113231751Stork U-Bag, Urine Collection Bag, 10mL, Preemie, Single Specimen, Cloth Adhesive, Sterile, 1/p
00840113231744Stork U-Bag, Urine Collection Bag, 100mL, Newborn, 24 Hour Specimen, Cloth Adhesive, Sterile, 1
00840113231737Stork U-Bag, Urine Collection Bag, 100mL, Newborn, Single Specimen, Cloth Adhesive, Sterile, 1/p
00840113231720Stork U-Bag, Urine Collection Bag, 200mL, Pediatric, 24 Hour Specimen, Cloth Adhesive, Sterile,
00840113231706Stork U-Bag, Urine Collection Bag, 200mL, Pediatric, Single Specimen, Cloth Adhesive, Sterile, 1

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