AccessGUDID - DEVICE: BD BACTEC™ MGIT™ 960 Supplement Kit (00382902451242)

GUDID

Device Identifier (DI) Information

Brand Name: BD BACTEC™ MGIT™ 960 Supplement Kit
Version or Model: 245124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 245124
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902451242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BACTEC™ MGIT™ 960 Supplement Kit

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58543	Blood culture broth kit IVD	A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDB	SYSTEM, BLOOD CULTURING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974883	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d508761b-cae2-4bc9-828f-625a7b77ab71
Public Version Date: July 18, 2024
Public Version Number: 4
DI Record Publish Date: May 25, 2018