Leakbuster

GUDID 00840165400815

Specimen Container, 120 ml, Orange Cap, Sterile.

Pretium Canada Packaging ULC

General specimen container IVD, no additive/medium

• Primary Device ID: 00840165400815
• NIH Device Record Key: 904fbd82-c82e-4698-845d-484d2bff81c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leakbuster
• Version Model Number: B1202-1O
• Company DUNS: 246665038
• Company Name: Pretium Canada Packaging ULC
• Device Count: 75
• 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	00840165400808 [Primary]
GS1	00840165400815 [Package]; Contains: 00840165400808; Package: [4 Units]; In Commercial Distribution
GS1	10840165400805 [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: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [Leakbuster]

• 00840165400815: Specimen Container, 120 ml, Orange Cap, Sterile.
• 00840165400792: Specimen Container, Space Saver Pack, 90 ml, Orange Cap, Sterile.
• 00840165400716: Specimen Container, 90 ml Opaque Vial, Sterile, Magenta Lined Cap.
• 00840165400693: Specimen Container, 90 ml, Sterile, Magenta Lined Cap.
• 00840165400679: Specimen Container, 90 ml, Sterile, White Cap.
• 00840165400655: Specimen Container, 90 ml, Sterile, Orange Cap.
• 00840165400631: Specimen Container, 60 ml, Sterile, Magenta Lined Cap.
• 00840165400617: Specimen Container, 60 ml, Sterile, Orange Cap
• 00840165401416: Specimen Container, 60 ml, Yellow Cap, No Label, Non-Sterile
• 00840165401195: Specimen Container, 60 ml, Yellow Cap, Non-Sterile