AccessGUDID - DEVICE: CENTRIMAG RVAS HDE KIT (07640135140603)

GUDID

Device Identifier (DI) Information

Brand Name: CENTRIMAG RVAS HDE KIT
Version or Model: 104318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 104318
Company Name: Thoratec Switzerland GmbH

Primary DI Number: 07640135140603
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:	Yes
Prescription Use (Rx):	Yes
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?
10847	External ventricular circulatory assist system	An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a electrically-powered external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJE	Right Ventricular Bypass (Assist) Device

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2cf1e96-1b00-42a2-8b16-8eb162b4d7dc
Public Version Date: August 20, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2014