AccessGUDID - DEVICE: CENTRIMAG® MEDICAL POWER CORD US / CANADA (07640135140337)

GUDID

Device Identifier (DI) Information

Brand Name: CENTRIMAG® MEDICAL POWER CORD US / CANADA
Version or Model: 102964
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102964
Company Name: Thoratec Switzerland GmbH

Primary DI Number: 07640135140337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486066918 *Terms of Use

Device Description: MEDICAL POWER CORD US / CANADA

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?
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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 Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 79.3 and 101.3 KiloPascal
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05d40bba-bb30-4676-9567-84595899c34c
Public Version Date: January 31, 2019
Public Version Number: 5
DI Record Publish Date: September 20, 2014