Oxicom 3000 Box Kit

Basic Information

• Brand Name: Oxicom 3000 Box Kit
• Primary DI: B154OXIKIT30003
• Version / Model: Oxicom 3000 Kit
• Catalog Number: 0006790.000
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• Labeler DUNS: 556957871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: a589d87f-4b5d-47e0-9443-995394ee9c1e
• Distribution End Date: 2023-12-15

Device Description

Oxicom 3000 Box Kit containing 100ct cuvette/plugs & QC 1,2,3 sticks

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15200	Intracardiac oximeter	A mains electricity (AC-powered) photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. It is typically used in conjunction with a fibreoptic oximeter catheter (e.g., a Swan-Ganz catheter) that is introduced via a vein in the groin or neck to measure mixed venous oxygen saturation (SvO2) or evaluate intracardiac shunts.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B154OXIKIT30003	HIBCC

Customer Contacts

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