AccessGUDID - DEVICE: BD BBL™ Motility Indole Ornithine Medium, Deeps (30382902215180)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Motility Indole Ornithine Medium, Deeps
Version or Model: 221518
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221518
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902215180
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™ Motility Indole Ornithine Medium, Deeps

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?
58636	Motility agar culture medium IVD	A selective and/or differential semi-solid agar culture medium intended to be used to determine the motility of gram-negative enteric bacilli isolated 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: a617aced-0092-452b-9f90-9635f47ea309
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2018