AccessGUDID - DEVICE: CUVETTES DC-80 Box 100 cuvettes & 100 plugs (B154O00103910003)

GUDID

Device Identifier (DI) Information

Brand Name: CUVETTES DC-80 Box 100 cuvettes & 100 plugs
Version or Model: Cuvette/Plug Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0010391.000
Company Name: WATERS MEDICAL SYSTEMS, LLC

Primary DI Number: B154O00103910003
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556957871 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f1915e7-f156-4e09-8a7c-ca7f7fc2d81c
Public Version Date: March 21, 2019
Public Version Number: 3
DI Record Publish Date: February 12, 2017