Leakbuster 3

Basic Information

• Brand Name: Leakbuster 3
• Primary DI: 00840165500331
• Version / Model: TW902-O-OR
• Company Name: Starplex Scientific Corp.
• Labeler DUNS: 859771235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-05-28
• Public Version: 1
• Public Version Date: 2025-06-05
• Public Version Status: New
• Public Device Record Key: 3fe3019a-30f1-4518-a819-88a2bc74479e

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	Container, Specimen, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840165500324	GS1
Primary	00840165500331	GS1