AccessGUDID - DEVICE: EM-TEC ADULT FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE (07640135140108)

GUDID

Device Identifier (DI) Information

Brand Name: EM-TEC ADULT FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE
Version or Model: 201-30105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201-30105
Company Name: Thoratec Switzerland GmbH

Primary DI Number: 07640135140108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486066918 *Terms of Use

Device Description: No description.

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?
62825	Extracorporeal fluid flow probe	An electronic device intended to be used to measure rate of fluid flow in an extracorporeal perfusion system tube using ultrasound transit time technology. It typically clamps over the exterior of a flexible tube and is used in conjunction with a flowmeter/flowmeter board incorporated into the perfusion system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWA	Control, pump speed, cardiopulmonary bypass

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
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70.2 and 110 KiloPascal
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 373ed78a-b8cc-4e13-b94c-237877c68629
Public Version Date: January 31, 2019
Public Version Number: 5
DI Record Publish Date: September 20, 2014