AccessGUDID - DEVICE: BD Phoenix™ NMIC-305 (30382904492947)

GUDID

Device Identifier (DI) Information

Brand Name: BD Phoenix™ NMIC-305
Version or Model: 449294
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 449294
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904492947
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2025
Device Count: 25
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Panel Phoenix NMIC-305

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?
43554	Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the identification and antimicrobial susceptibility profile of bacteria species isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LON	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e1209c5-c8bd-425f-9c9d-a7c562392927
Public Version Date: February 19, 2025
Public Version Number: 2
DI Record Publish Date: October 24, 2023