AccessGUDID - DEVICE: BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar (10382902216237)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar
Version or Model: 221623
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221623
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902216237
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Plate Bi Choc II & MTM II 20 Ea

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
JTY	CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K760588	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: 516305c8-84cb-4e00-b116-baf4ce48b6b4
Public Version Date: October 25, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30382902216231	2	10382902216237	2022-03-14	Not in Commercial Distribution	Shelfpack
60382902216232	400	30382902216231	2022-03-14	Not in Commercial Distribution	US pallet