AccessGUDID - DEVICE: EDGE BIOLOGICALS INC (B6454P011)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE BIOLOGICALS INC
Version or Model: 4P011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EDGE BIOLOGICALS, INC.

Primary DI Number: B6454P011
Issuing Agency: HIBCC
Commercial Distribution End Date: April 16, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 047927827 *Terms of Use

Device Description: CDC ANA BAP

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?
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSH	Culture Media, Non-Selective And Differential

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: c5dcc18a-fa88-4c47-b859-b1245600ee67
Public Version Date: April 24, 2025
Public Version Number: 1
DI Record Publish Date: April 16, 2025