GEM OPL (220V)

Basic Information

• Brand Name: GEM OPL (220V)
• Primary DI: 08426950490791
• Version / Model: 06320480001
• Catalog Number: 06320480001
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 8
• Public Version Date: 2024-01-26
• Public Version Status: Update
• Public Device Record Key: f124169f-39ab-4484-99b3-ba6aa6be4755
• Distribution End Date: 2024-01-25

Device Description

GEM OPL (220V)

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide	Clinical Toxicology	862.3220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56663	Blood gas/haemoximetry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950490791	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951485	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius