AccessGUDID - DEVICE: VerifyNow System (10711234150108)

GUDID

Device Identifier (DI) Information

Brand Name: VerifyNow System
Version or Model: 85063
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85063
Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Primary DI Number: 10711234150108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079299318 *Terms of Use

Device Description: VerifyNow System Validation 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):	Yes
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?
56699	Platelet aggregation analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOZ	System, Automated Platelet Aggregation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992531	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: a042f5b9-0aab-4c89-97f5-e30a6c3ed93d
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: September 22, 2016