AccessGUDID - DEVICE: EXCOR® VAD (04260090040515)

GUDID

Device Identifier (DI) Information

Brand Name: EXCOR® VAD
Version or Model: C18A-020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Berlin Heart GmbH

Primary DI Number: 04260090040515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328654384 *Terms of Use

Device Description: Apex cannula for small children

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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 mains electricity (AC-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.

GMDN Preferred Term Name

GMDN Definition

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 mains electricity (AC-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.

FDA Product Code

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Product Code	Product Code Name
DSQ	Ventricular (Assisst) Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H100004	003
H100004	004
H100004	006
H100004	008
H100004	013
H100004	017
H100004	021
P160035	000

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

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Storage and Handling
Storage Environment Humidity: between 35 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 004de083-5adc-452e-b04f-14c2fcd2fa6b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014