XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.

Basic Information

• Brand Name: XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.
• Primary DI: 00850027193045
• Version / Model: 60601
• Company Name: Steripack (usa) Limited LLC
• Labeler DUNS: 042126640
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2022-10-03
• Public Version: 1
• Public Version Date: 2022-10-11
• Public Version Status: New
• Public Device Record Key: ab626662-3b07-40b0-b6c3-895ab46461db

Device Description

single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares

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: Yes
• Sterilization Methods: Radiation Sterilization

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
54970	Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Hu antibodies in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850027193359	GS1
Primary	00850027193045	GS1