Edwards Certitude Delivery System 9630TA23A

GUDID 00690103201185

Edwards Certitude Delivery System

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

Primary Device ID	00690103201185
NIH Device Record Key	e35c730a-4f23-4ffe-b9ff-6bbce7f698fe
Commercial Distribution Status	In Commercial Distribution
Brand Name	Edwards Certitude Delivery System
Version Model Number	9630TA23
Catalog Number	9630TA23A
Company DUNS	134139174
Company Name	Edwards Lifesciences LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Must be stored in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103201185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P140031

FDA Product Code

NPU	Prosthesis, Mitral Valve, Percutaneously Delivered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-06-07
Device Publish Date	2019-01-08

On-Brand Devices [Edwards Certitude Delivery System]

00690103201451	Edwards Certitude Delivery System
00690103201444	Edwards Certitude Delivery System
00690103201192	Edwards Certitude Delivery System
00690103201185	Edwards Certitude Delivery System
00690103194166	EDWARDS CERTITUDE DELIVERY SYSTEM
00690103194159	EDWARDS CERTITUDE DELIVERY SYSTEM
00690103194142	EDWARDS CERTITUDE DELIVERY SYSTEM
00690103194135	EDWARDS CERTITUDE DELIVERY SYSTEM