Leakbuster

GUDID 00840165500393

Specimen Container, 90 ml, Orange Cap, Applied Temperature Strip, Sterile.

Starplex Scientific Corp.

Drug-testing urine specimen container IVD

• Primary Device ID: 00840165500393
• NIH Device Record Key: 8410fef1-0cc8-48b6-a9fc-16708130d6a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leakbuster
• Version Model Number: B902-1OTS
• 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	00840165500386 [Unit of Use]
GS1	00840165500393 [Package]; Contains: 10840165500383; Package: [4 Units]; In Commercial Distribution
GS1	10840165500383 [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]

• 00840165500034: Specimen Container, 120 ml, Orange Cap, Sterile.
• 00840165500010: Specimen Container, 90 ml, Orange Cap, Sterile.
• 00840165500539: Specimen Container, 120 ml, White Cap, Sterile.
• 00840165500478: Specimen Container, 90 ml Wide Mouth, White Cap, Applied Temperature Strip, Sterile.
• 00840165500454: Specimen Container, 90 ml Wide Mouth, Orange Cap, Applied Temperature Strip, Sterile.
• 00840165500430: Specimen Container, 90 ml, White Cap, No Label, Applied Temperature Strip, Non-Sterile.
• 00840165500416: Specimen Container, 90 ml, Yellow Cap, Applied Temperature Strip, Non-Sterile.
• 00840165500393: Specimen Container, 90 ml, Orange Cap, Applied Temperature Strip, Sterile.
• 00840165500355: Specimen Container, 90 ml, White Cap, Sterile.
• 00840165500171: Specimen Container, 90 ml Wide Mouth, Orange Cap, Applied Temperature Strip, Non-Sterile
• 00840165500157: Specimen Container, 120 ml, Yellow Cap, Non-Sterile.
• 00840165500133: Specimen Container, 90 ml Wide Mouth, Yellow Cap, Non-Sterile.
• 00840165500119: Specimen Container, 90 ml, Yellow Cap, Non-Sterile.
• 00840165500058: Specimen Container, 90 ml Wide Mouth, Orange Cap, Sterile.
• 00840165500508: Specimen Container, 120 ml, Orange Cap, Individually Packaged in Peel Pack, Sterile.
• 00840165500485: Specimen Container, 120 ml, Orange Cap, Individually Packaged in Peel Pack with Castile Soap Tow
• 00840165500362: Specimen Container, 120 ml, White Cap, Individually Packaged in Peel Pack, Sterile.