Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10885380141140
• Version / Model: CA8475
• Catalog Number: CA8475
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-12
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: cf54a5be-916b-4fd5-a9a1-c3301d7bdae3

Device Description

DNA COLLECTION KIT, PRESCIENT ONLY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
LRP	TRAY, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63678	Saliva/oral specimen collection kit, no additive	A collection of devices intended to be used for the collection, preservation, and transport of salivary, cellular, and/or other material collected from the mouth for laboratory analysis [e.g., by nucleic acid technique (NAT), microbiological culture]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], and a covered empty plastic receptacle. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380141148	GS1	CASE	50	In Commercial Distribution
Primary	10885380141140	GS1