AccessGUDID - DEVICE: InTray® SAB+PVG (B088212730010)

GUDID

Device Identifier (DI) Information

Brand Name: InTray® SAB+PVG
Version or Model: 2127
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B088212730010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: InTray SAB+PVG is for growth and observation of fungi, yeasts and dermatophytes. Inhibition is enhanced with the introduction of Polymyxin B, Vancomycin and Gentamicin.

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?
33358	Multiple dermatophyte species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of dermatophyte or other fungi isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSJ	Culture Media, Selective And Non-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: No
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: 51b0a364-0c42-40b7-81b3-d72dd2053fb5
Public Version Date: October 13, 2023
Public Version Number: 1
DI Record Publish Date: October 05, 2023