UR-Assure

GUDID 10687225301852

Pediatric Urine Collectors, Sterile, 160MIL

PRECISION DYNAMICS CORPORATION

Adhesive infant/paediatric urine collection bag, open-ended

• Primary Device ID: 10687225301852
• NIH Device Record Key: dee6a01a-7f56-4ff0-9975-5b49b0515def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UR-Assure
• Version Model Number: 05002-00-MCF
• Company DUNS: 008486367
• Company Name: PRECISION DYNAMICS CORPORATION
• Device Count: 50
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10687225301852 [Primary]
GS1	80687225301851 [Unit of Use]

FDA Product Code

• EXI: Device, Paste-On For Incontinence, Sterile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-10-25

On-Brand Devices [UR-Assure ]

• 10687225301876: Pediatric Urine Collectors, 160MIL, Clean (non-sterile), 50 Qty
• 10687225301852: Pediatric Urine Collectors, Sterile, 160MIL