AccessGUDID - DEVICE: BD BACTEC™ Platelet Anaerobic/F Culture Vials (00382904420543)

GUDID

Device Identifier (DI) Information

Brand Name: BD BACTEC™ Platelet Anaerobic/F Culture Vials
Version or Model: 442054
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 442054
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904420543
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BACTEC™ Platelet Anaerobic/F Culture Vials

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58556	Culture medium antimicrobial supplement IVD	A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZC	System, detection, bacterial, for platelet transfusion products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK180211	000
BK200530	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: Patient number
Special Storage Condition, Specify: Collection time
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from light

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 40 Milliliter

Device Record Status

Public Device Record Key: 076688c7-305c-4190-b205-f1463dd8823d
Public Version Date: May 21, 2025
Public Version Number: 4
DI Record Publish Date: October 05, 2023