AccessGUDID - DEVICE: VisuCon-F Frozen Normal Control Plasma (10629009051256)

GUDID

Device Identifier (DI) Information

Brand Name: VisuCon-F Frozen Normal Control Plasma
Version or Model: FRNCP0125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Affinity Biologicals Inc

Primary DI Number: 10629009051256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 249373515 *Terms of Use
Previous DI: 16290090051254

Device Description: Intended for use in the quality control of coagulation assays in the normal range.

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:	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?
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
GGN	Plasma, Coagulation Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091284	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
Special Storage Condition, Specify: Store at or below -60°C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32782de4-e80c-4600-a337-a06d7a76945b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 28, 2017