AccessGUDID - DEVICE: BD BBL™ Enterococcosel™ Agar (10382902214929)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Enterococcosel™ Agar
Version or Model: 221492
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221492
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902214929
Issuing Agency: GS1
Commercial Distribution End Date: April 07, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Plate Enterococcosel Agar 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?
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
JSI	CULTURE MEDIA, 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
Depth: 15 Millimeter
Outer Diameter: 100 Millimeter

Device Record Status

Public Device Record Key: 7c7b2d26-ac15-468d-b4a7-920cc32953e2
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
60382902214924	400	30382902214923	2022-04-07	Not in Commercial Distribution	US pallet
30382902214923	2	10382902214929	2022-04-07	Not in Commercial Distribution	Shelfpack