CUVETTES DC-80 Box 100 cuvettes & 100 plugs

Basic Information

• Brand Name: CUVETTES DC-80 Box 100 cuvettes & 100 plugs
• Primary DI: B154O00103910003
• Version / Model: Cuvette/Plug Kit
• Catalog Number: 0010391.000
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• Labeler DUNS: 556957871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 3
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 4f1915e7-f156-4e09-8a7c-ca7f7fc2d81c

Device Description

Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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	B154O00103910003	HIBCC
Package	0034791000	HIBCC	Half Case	3	In Commercial Distribution
Package	0033991000	HIBCC	Case	6	In Commercial Distribution

Customer Contacts

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