AccessGUDID - DEVICE: CDI® Blood Parameter Monitoring System 550 (00886799001783)

GUDID

Device Identifier (DI) Information

Brand Name: CDI® Blood Parameter Monitoring System 550
Version or Model: 550AVHCT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550AVHCT
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799001783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: Monitor with two blood parameter modules and one H/S Probe.

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?
37238	Extracorporeal blood gas/pH monitor	A mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery.	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 [?]
K182110	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d9bcc78-6882-4b27-a018-fa58703b2b62
Public Version Date: December 10, 2018
Public Version Number: 1
DI Record Publish Date: November 09, 2018