EDGE BIOLOGICALS INC

Basic Information

• Brand Name: EDGE BIOLOGICALS INC
• Primary DI: B645T0616
• Version / Model: T0616
• Company Name: EDGE BIOLOGICALS, INC.
• Labeler DUNS: 047927827
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-04-17
• Public Version: 1
• Public Version Date: 2025-04-25
• Public Version Status: New
• Public Device Record Key: d69a636f-854f-4bfc-89cb-8850efca93ff
• Distribution End Date: 2025-04-17

Device Description

SALINE 0.85% 5ML

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
JSC	Culture Media, General Nutrient Broth	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58673	Saline suspension medium/diluent IVD	A saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B645T06161	HIBCC
Primary	B645T0616	HIBCC