U-Bag Urine Collector

GUDID 00840113231744

Stork U-Bag, Urine Collection Bag, 100mL, Newborn, 24 Hour Specimen, Cloth Adhesive, Sterile, 1/pouch, 50 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 ID00840113231744
NIH Device Record Keybc1b338f-9945-42c1-a4be-03d6c93136a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Bag Urine Collector
Version Model Number7537
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
GS100840113231744 [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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