AccessGUDID - DEVICE: BD Phoenix™ AP ID Broth (30382904480128)

GUDID

Device Identifier (DI) Information

Brand Name: BD Phoenix™ AP ID Broth
Version or Model: 448012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 448012
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904480128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Phoenix™ AP ID Broth

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:	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?
42651	Buffered isotonic saline reagent IVD	A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 800 Milliliter

Device Record Status

Public Device Record Key: d0ea64d8-703c-4ba8-8a70-851a764e4782
Public Version Date: July 18, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2018