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

• Primary Device ID: 00840113231744
• NIH Device Record Key: bc1b338f-9945-42c1-a4be-03d6c93136a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Bag Urine Collector
• Version Model Number: 7537
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840113231744 [Primary]

FDA Product Code

• FAQ: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-07
• Device Publish Date: 2023-02-27

On-Brand Devices [U-Bag Urine Collector]

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