Colli-Pee N00342

GUDID 00627595001719

Urine Collection Container

DNA Genotek Inc

Urine specimen collection kit IVD

• Primary Device ID: 00627595001719
• NIH Device Record Key: fe167ba0-461d-4e32-afcb-236f4c910de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colli-Pee
• Version Model Number: Colli-Pee UAS FV-5040
• Catalog Number: N00342
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595001719 [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