AccessGUDID - DEVICE: BD BACTEC™ Digital Thermometer (00382904413705)

GUDID

Device Identifier (DI) Information

Brand Name: BD BACTEC™ Digital Thermometer
Version or Model: 441370
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 441370
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904413705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BACTEC™ Digital Thermometer

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?
56739	Blood culture analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDB	System, blood culturing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915796	000

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: 3853d9fd-7815-4c37-b80c-9db3da971382
Public Version Date: August 30, 2024
Public Version Number: 1
DI Record Publish Date: August 22, 2024