Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 00810010893093
• Version / Model: AMM5975
• Catalog Number: AMM5975
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 594239a6-a2e9-4c3b-8158-03a39aae6568

Device Description

Oral Fluid Kit

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: Yes
• 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
KDT	CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE	Pathology	864.3250	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	50810010893098	GS1	CASE	1	In Commercial Distribution
Primary	00810010893093	GS1