eSwab™

Basic Information

• Brand Name: eSwab™
• Primary DI: 38053326005368
• Version / Model: 493C02
• Catalog Number: 493C02
• Company Name: COPAN ITALIA SPA
• Labeler DUNS: 428981112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 6b439a24-1a12-4b74-9f2d-0cf3ed25b74c

Device Description

1 LQ AMIES TEST TUBE + 1 PINK APPLICATORS + 1 WHITE APPLICATOR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JTW	System, Transport, Aerobic	Microbiology	866.2900	1
JTX	Transport Systems, Anaerobic	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	58053326005362	GS1		10	In Commercial Distribution
Primary	38053326005368	GS1
Unit of Use	18053326005364	GS1
Package	68053326005369	GS1		8	In Commercial Distribution