AccessGUDID - DEVICE: CRYOcheck™ APCR Positive Control (00843876000183)

GUDID

Device Identifier (DI) Information

Brand Name: CRYOcheck™ APCR Positive Control
Version or Model: APCR-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Precision Biologic Inc

Primary DI Number: 00843876000183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 244713368 *Terms of Use

Device Description: No description.

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:	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?
45791	Activated protein C resistant factor V (factor V Leiden) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of factor V Leiden, a clotting protein resistant to cleavage by activated protein C, 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 [?]
K971222	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: 8879f248-9ade-481b-9047-36d7b6cdc5ee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016