AccessGUDID - DEVICE: BD BACTEC™ Myco/F Lytic Culture Vials (00382904422882)

GUDID

Device Identifier (DI) Information

Brand Name: BD BACTEC™ Myco/F Lytic Culture Vials
Version or Model: 442288
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 442288
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904422882
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BACTEC™ Myco/F Lytic 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):	No

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
MDB	System, blood culturing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970333	000
K970512	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: Fragile, handle with care
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f407c887-cae9-43f3-b49f-c7d06ae2dbc8
Public Version Date: May 15, 2025
Public Version Number: 2
DI Record Publish Date: February 07, 2025