AccessGUDID - DEVICE: BD BBL™ GC II Agar with IsoVitaleX™ Enrichment (10382902212406)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ GC II Agar with IsoVitaleX™ Enrichment
Version or Model: 221240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221240
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902212406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ GC II Agar with IsoVitaleX™ Enrichment, Pkg. of 8 plates (150 x 15 mm-style)

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?
58603	Fastidious-microorganism antimicrobial susceptibility culture medium IVD	A supplemented culture medium enriched with blood and/or other additives intended to be used to perform diagnostic antimicrobial susceptibility testing on fastidious microorganisms isolated from a clinical specimen.	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 [?]
K945569	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: 150 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 2babbdd2-d69c-4dac-ba47-e1d0e0ebccf8
Public Version Date: August 16, 2024
Public Version Number: 4
DI Record Publish Date: December 21, 2016