Sterile Polyester Spun Swab 25 Ct. Pouch

Basic Information

• Brand Name: Sterile Polyester Spun Swab 25 Ct. Pouch
• Primary DI: 00850027193243
• Version / Model: 60594
• Company Name: Steripack (usa) Limited LLC
• Labeler DUNS: 042126640
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• 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: 78db3802-555f-48ac-9a37-057127f9e37d

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
Package	00860004112792	GS1	Case Box	1875	In Commercial Distribution
Primary	00850027193243	GS1
Unit of Use	00850027193199	GS1