AccessGUDID - DEVICE: BD BBL™ Enterococcus Screen Agar QUAD Plate (10382902222016)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Enterococcus Screen Agar QUAD Plate
Version or Model: 222201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 222201
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902222016
Issuing Agency: GS1
Commercial Distribution End Date: June 16, 2017
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Enterococcus Screen 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):	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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual antimicrobial susceptibility test systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951539	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
Depth: 15 Millimeter
Outer Diameter: 100 Millimeter

Device Record Status

Public Device Record Key: abd01218-3000-499a-99bf-96cabbff2ac7
Public Version Date: November 30, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2016