AccessGUDID - DEVICE: BD (00382906630285)

GUDID

Device Identifier (DI) Information

Brand Name: BD
Version or Model: 663028
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 663028
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382906630285
Issuing Agency: GS1
Commercial Distribution End Date: February 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: BD Trucount™ Tubes

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:	No
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?
56919	Multiple CD cell marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b4eb971-b8cc-48ce-9e68-cf65c8ab2261
Public Version Date: October 14, 2024
Public Version Number: 6
DI Record Publish Date: January 10, 2018