Starplex

GUDID 10840165400867

10 ml Urine Preservative Vial, for Urine Culture and Urinalysis, Sterile

Pretium Canada Packaging ULC

Non-evacuated urine specimen container IVD, preservative

• Primary Device ID: 10840165400867
• NIH Device Record Key: 6c652eb6-eac3-4de6-8ada-938ce3aceb4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Starplex
• Version Model Number: V102-CA
• Company DUNS: 246665038
• Company Name: Pretium Canada Packaging ULC
• Device Count: 500
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	00840165400860 [Primary]
GS1	10840165400867 [Unit of Use]

FDA Product Code

• FMH: Container, Specimen, 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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [Starplex]

• 10840165400874: 10 ml Vial with White Cap, Individually Peel Packed, Sterile.
• 00840165400754: 30 ml Collector, White Cap, Sterile.
• 00840165400976: Specimen Container, 30 ml, Fecal Spork, Non-Sterile.
• 10840165400867: 10 ml Urine Preservative Vial, for Urine Culture and Urinalysis, Sterile