Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 00810010894748
• Version / Model: AMM18875
• Catalog Number: AMM18875
• Company Name: AERO-MED, LLC
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-11
• Public Version: 2
• Public Version Date: 2025-05-29
• Public Version Status: Update
• Public Device Record Key: b96bf1fe-ae04-433a-bb5c-748fd5a780c5

Device Description

Prostate Biopsy Transport Kit-8 Place

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
OIB	Blood and urine collection kit (excludes HIV testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50810010894743	GS1	CASE	10	In Commercial Distribution
Primary	00810010894748	GS1