AccessGUDID - DEVICE: BD BBL™ Sabouraud Dextrose Agar (Deep Fill) (10382902211805)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Sabouraud Dextrose Agar (Deep Fill)
Version or Model: 221180
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221180
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902211805
Issuing Agency: GS1
Commercial Distribution End Date: March 23, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Sabouraud Dextrose 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?
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	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: 5e0f209e-355d-41bf-ba7c-20e4a3a8b12a
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
30382902211809	2	10382902211805	2022-03-23	Not in Commercial Distribution	Shelfpack
60382902211800	400	30382902211809	2022-03-23	Not in Commercial Distribution	US pallet