AccessGUDID - DEVICE: BD BBL™ Crystal™ GP Gram-Positive ID System (30382902452400)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Crystal™ GP Gram-Positive ID System
Version or Model: 245240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 245240
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902452400
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2022
Device Count: 20
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Crystal™ GP Gram-Positive ID System

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?
50419	Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQL	GRAM POSITIVE IDENTIFICATION PANEL

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f58bdcd0-2c99-42b5-901a-97d1006f0e80
Public Version Date: October 23, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018