Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 00810010894960
• Version / Model: AMM20800
• Catalog Number: AMM20800
• Company Name: AERO-MED, LLC
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-17
• Public Version: 1
• Public Version Date: 2026-03-25
• Public Version Status: New
• Public Device Record Key: 27119b2e-5f4f-415c-8151-e0f876123924

Device Description

Blood Sample Collection 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
PQD	Blood specimen collection convenience kit (excludes HIV)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810010894960	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius