GEM CVP (Calibration Validation Product) Level 4

Basic Information

• Brand Name: GEM CVP (Calibration Validation Product) Level 4
• Primary DI: 08426950358763
• Version / Model: 00024001814
• Catalog Number: 00024001814
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 2f3c7ca5-e277-4c87-8bbe-6664bb5c2f49

Device Description

GEM CVP (Calibration Validation Product) Level 4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52860	Multiple blood gas/haemoximetry/electrolyte analyte IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950358763	GS1
Unit of Use	18426950358760	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052121	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius