AccessGUDID - DEVICE: Pointe Scientific, Inc. (00811727014481)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific, Inc.
Version or Model: C7548-120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7548-120
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727014481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 1 x 90 mL, 1 x 30 mL

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?
53250	Creatinine IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JFY	Enzymatic Method, Creatinine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050283	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: 4cc9f64e-a07d-417d-b6b8-37326a3ae9a9
Public Version Date: December 20, 2022
Public Version Number: 4
DI Record Publish Date: August 31, 2016