AccessGUDID - DEVICE: BD BBL™ Crystal™ ID Systems Anaerobe Manual Codebook (00382902450115)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Crystal™ ID Systems Anaerobe Manual Codebook
Version or Model: 245011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 245011
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902450115
Issuing Agency: GS1
Commercial Distribution End Date: September 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Codebook Crystal Anaerobe Id

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:	No
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?
56742	Microorganism identification analyser IVD, manual	An electrically-powered manual laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSP	KIT, ANAEROBIC IDENTIFICATION

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a4df676-efc5-44be-b86c-95545dd5a710
Public Version Date: October 23, 2023
Public Version Number: 3
DI Record Publish Date: May 25, 2018