AccessGUDID - DEVICE: CRYOcheck™ Factor X Deficient Plasma (00843876000336)

GUDID

Device Identifier (DI) Information

Brand Name: CRYOcheck™ Factor X Deficient Plasma
Version or Model: FDP10-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Precision Biologic Inc

Primary DI Number: 00843876000336
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?
30595	Multiple coagulation factor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
56037	Coagulation factor X IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor X in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJT	Plasma, Coagulation Factor Deficient

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971227	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: ece04865-4be0-41af-a7b6-9d035ce803f4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016