AccessGUDID - DEVICE: BD Multiset&#8482; (00382903431786)

GUDID

Device Identifier (DI) Information

Brand Name: BD Multiset™
Version or Model: 343178
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 343178
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903431786
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: Simulset V3.1 Update Kit

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
42838	Laboratory analyser operation system software IVD	Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923790	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50aedcff-fd85-4140-9d36-d24d85b92327
Public Version Date: October 03, 2023
Public Version Number: 4
DI Record Publish Date: June 08, 2016