AccessGUDID - DEVICE: BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA (10382902153594)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA
Version or Model: 215359
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 215359
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902153594
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA

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):	Yes
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?
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092767	000

Device Exempt from Premarket Submission: No 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
Outer Diameter: 100 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 63ed861b-540e-428b-b360-d27c5edee9d4
Public Version Date: November 10, 2023
Public Version Number: 4
DI Record Publish Date: December 16, 2016