AccessGUDID - DEVICE: InTray® SMA (B08814230)

GUDID

Device Identifier (DI) Information

Brand Name: InTray® SMA
Version or Model: 1423
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-423-001
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08814230
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."

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?
58671	Sorbitol-MacConkey E. coli agar culture medium IVD	A selective and/or differential MacConkey agar culture medium containing sorbitol intended to be used for the growth and isolation of E. coli O157: H7 from a clinical specimen, based on fermentation of sorbitol.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSI	Culture Media, 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3857cad3-0f13-407a-928d-104afe12d291
Public Version Date: October 15, 2018
Public Version Number: 1
DI Record Publish Date: September 12, 2018