AccessGUDID - DEVICE: ExpertCor Routine (00864608000226)

GUDID

Device Identifier (DI) Information

Brand Name: ExpertCor Routine
Version or Model: 01306
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DSRV Inc

Primary DI Number: 00864608000226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079613839 *Terms of Use

Device Description: ExpertCor Routine plasma set consists of unassayed, ready-to-use human plasmas across reportable range of prothrombin time (PT), activated partial thromboplastin time (APTT), Fibrinogen and INR. The plasma set is intended for use in the quality control of coagulation assay performed on Coagulation Analyzers.

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):	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?
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 77f6612c-44d3-46f6-ab85-f40823ee9921
Public Version Date: May 29, 2024
Public Version Number: 1
DI Record Publish Date: May 21, 2024