Leakbuster 3

GUDID 00840165500300

Specimen Container, 90 ml, Tamper Evident Orange Cap, Individually Packaged in Peel Pack with Castile Soap Towelette, Sterile.

Starplex Scientific Corp.

Midstream urine specimen container IVD

• Primary Device ID: 00840165500300
• NIH Device Record Key: cc84a8d3-cc18-4dee-a502-233c3ea5b94e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leakbuster 3
• Version Model Number: TW952-O
• Company DUNS: 859771235
• Company Name: Starplex Scientific Corp.
• Device Count: 100
• 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	00840165500300 [Unit of Use]
GS1	00840165500317 [Primary]

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: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [Leakbuster 3]

• 00840165500294: Specimen Container, 90 ml, Tamper Evident Orange Cap, Sterile.
• 00840165500324: Specimen Container, 90 ml, Tamper Evident Orange Cap, Individually Packaged in Peel Pack, Steril
• 00840165500300: Specimen Container, 90 ml, Tamper Evident Orange Cap, Individually Packaged in Peel Pack with Ca