Colli-Pee N00309

GUDID 00627595001634

Urine Collection Container

DNA Genotek Inc

General specimen container IVD, no additive/medium

• Primary Device ID: 00627595001634
• NIH Device Record Key: 45f6bdd9-0a1f-484a-bfcd-5b643280c06b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colli-Pee
• Version Model Number: Colli-Pee FV-5010
• Catalog Number: N00309
• Company DUNS: 207983508
• Company Name: DNA Genotek 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595001634 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [Colli-Pee]

• 00627595001719: Urine Collection Container
• 00627595001702: Urine Collection Container
• 00627595001696: Urine Collection Container
• 00627595001689: Urine Collection Container
• 00627595001672: Urine Collection Container
• 00627595001665: Urine Collection Container
• 00627595001658: Urine Collection Container
• 00627595001641: Urine Collection Container
• 00627595001634: Urine Collection Container
• 00627595001627: Urine Collection Container