AccessGUDID - DEVICE: BD BBL™ GC-Lect™ Agar (10382902979286)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ GC-Lect™ Agar
Version or Model: 297928
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 297928
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902979286
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ GC-Lect™ 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?
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
JTY	CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864803	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 100 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 5714b636-b4d4-460c-94be-35028ac999da
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
30382902979280	10	10382902979286	2022-03-29	Not in Commercial Distribution	Shelfpack
60382902979281	96	30382902979280	2022-03-29	Not in Commercial Distribution	US pallet