EDGE BIOLOGICALS INC

Basic Information

• Brand Name: EDGE BIOLOGICALS INC
• Primary DI: B6454P022
• Version / Model: 4P022
• Company Name: EDGE BIOLOGICALS, INC.
• Labeler DUNS: 047927827
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-04-16
• Public Version: 1
• Public Version Date: 2025-04-24
• Public Version Status: New
• Public Device Record Key: 9c1c0ad7-766a-4774-9f8d-6c9fcdf0ce80
• Distribution End Date: 2025-04-16

Device Description

BHI BLOOD W/ C&C

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSJ	Culture Media, Selective And Non-Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43344	Tissue culture/microbiology petri dish, single-use	A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6454P022	HIBCC
Unit of Use	B6454P0221	HIBCC