AccessGUDID - DEVICE: BD BACTEC™ Plus Aerobic/F Culture Vials (00382904421922)

GUDID

Device Identifier (DI) Information

Brand Name: BD BACTEC™ Plus Aerobic/F Culture Vials
Version or Model: 442192
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 442192
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904421922
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Bactec Plus Aerobic/F 50/Pk F/G

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:	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?
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 [?]
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
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: c78f07bc-c258-4f1e-b99c-a52e05a19e46
Public Version Date: October 30, 2023
Public Version Number: 3
DI Record Publish Date: May 25, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30382904421923	50	00382904421922	2023-06-30	Not in Commercial Distribution	Shelfpack
60382904421924	70	30382904421923	2023-06-30	Not in Commercial Distribution	US pallet