AccessGUDID - DEVICE: CDI OneView™ Monitoring System (00886799001950)

GUDID

Device Identifier (DI) Information

Brand Name: CDI OneView™ Monitoring System
Version or Model: CDI763
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CDI763
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799001950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: CDI OneView™ Flow Sensor 3/8" x 3/32"

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
36356	Cardiopulmonary bypass system pressure monitor	A mains electricity (AC-powered) device used to electronically measure the pressure in a cardiopulmonary bypass system (e.g., in the extracorporeal tubing circuit); it may provide an alarm if pressure levels exceed operator-set limits. It is typically a module of the heart-lung bypass system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234065	000

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
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Storage Environment Temperature: between 32 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98a659f8-92f6-4d9a-b759-510e80d4b524
Public Version Date: July 31, 2024
Public Version Number: 1
DI Record Publish Date: July 23, 2024