AccessGUDID - DEVICE: Mission Trinity B, Level 2 (00811403014811)

GUDID

Device Identifier (DI) Information

Brand Name: Mission Trinity B, Level 2
Version or Model: DD-96002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diamond Diagnostics Inc.

Primary DI Number: 00811403014811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947514303 *Terms of Use

Device Description: For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter instrumentation for the analytes and analyzers listed on the Expected Values Chart.

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?
30218	Multiple blood gas analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ac14807-d9a1-47e0-b112-0e3ada5fd4e5
Public Version Date: June 16, 2023
Public Version Number: 2
DI Record Publish Date: June 05, 2023