AccessGUDID - DEVICE: EDGE BIOLOGICALS INC (B645T0601)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE BIOLOGICALS INC
Version or Model: T0601
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EDGE BIOLOGICALS, INC.

Primary DI Number: B645T0601
Issuing Agency: HIBCC
Commercial Distribution End Date: April 17, 2025
Device Count: 100
Labeler D-U-N-S® Number*: 047927827 *Terms of Use

Device Description: SALINE 0.45% 3ML

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSC	Culture Media, General Nutrient Broth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e4c0340-5339-4d0e-9042-15738d6e4970
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025