AccessGUDID - DEVICE: Pointe Creatine Kinase Reagent (00811727016096)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Creatine Kinase Reagent
Version or Model: 16-C7522-225
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16-C7522-225
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727016096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Creatine Kinase Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 15ml R2. For the quantitative determination of creatine kinase activity in serum.

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?
53001	Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972155	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3060b649-ad9e-4a5f-959b-8c20fbeca55e
Public Version Date: February 08, 2021
Public Version Number: 1
DI Record Publish Date: January 30, 2021