Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10885380183980
• Version / Model: CA35050
• Catalog Number: CA35050
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-24
• Public Version: 6
• Public Version Date: 2023-02-01
• Public Version Status: Update
• Public Device Record Key: b03b5966-8a75-4b04-b78d-e903fd555744
• Distribution End Date: 2023-02-01

Device Description

Viral Collection Transport Kit, SLC Health System Only

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIB	Blood and urine collection kit (excludes HIV testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62773	General specimen collection kit IVD, clinical	A collection of in vitro diagnostic 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 in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological 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	50885380183988	GS1	CASE	50	Not in Commercial Distribution	2023-02-01
Primary	10885380183980	GS1