CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 270019MM

GUDID 00690103021585

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID00690103021585
NIH Device Record Key8fb048d5-2777-45fb-a637-680c7d254abd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC
Version Model Number2700
Catalog Number270019MM
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse

Customer Support Contacts

Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103021585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYEreplacement Heart-valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-08-30

On-Brand Devices [CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC]

006901030216392700
006901030216222700
006901030216152700
006901030216082700
006901030215922700
006901030215852700

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