AccessGUDID - DEVICE: BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB Agar (10382902212895)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB Agar
Version or Model: 221289
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221289
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902212895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB 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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	CULTURE MEDIA, NON-SELECTIVE AND NON-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
Outer Diameter: 100 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: f04d4d11-8fbd-4971-91bf-e4e10493f580
Public Version Date: August 21, 2024
Public Version Number: 5
DI Record Publish Date: May 25, 2018