Specimen Collection Swab

Basic Information

• Brand Name: Specimen Collection Swab
• Primary DI: 08809262394092
• Version / Model: FASPS10
• Company Name: HLB CO.,LTD
• Labeler DUNS: 987587913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-10-28
• Public Version: 1
• Public Version Date: 2025-11-05
• Public Version Status: New
• Public Device Record Key: f544ae83-1305-4f70-8e81-7ed9a414c88e

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59740	Ornithine carbamoyltransferase deficiency IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder ornithine carbamoyltransferase deficiency, an X-linked inborn error of metabolism of the urea cycle, associated with mutations in the OTC gene.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08809262394054	GS1
Primary	08809262394092	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]