AccessGUDID - DEVICE: BD BBL™ Bovine Serum (30382902974582)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Bovine Serum
Version or Model: 297458
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 297458
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902974582
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Bovine Serum

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?
62108	Candida albicans microbial identification reagent IVD	A substance or reactant containing serum, intended to be used in microbial testing to perform a germ tube test for the identification of Candida albicans isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSH	CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: f4c652c4-8509-4a18-855f-befa1d427771
Public Version Date: October 17, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018