POINTE SCIENTIFIC Carbon Dioxide Standard

Basic Information

• Brand Name: POINTE SCIENTIFIC Carbon Dioxide Standard
• Primary DI: 00811727010698
• Version / Model: C7504-STD
• Catalog Number: C7504-STD
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: befae98e-6c2c-4a77-b6ce-961893ff6894

Device Description

Intended for use as an carbon dioxide standard for standardization or calibration of PECP / NADH analog carbon dioxide procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	862.1160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60771	Carbon dioxide (CO2) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727010698	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K012332	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius