THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE ICF100

GUDID 00690103190007

INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

Edwards Lifesciences LLC

Intravascular occluding balloon catheter, image-guided

Primary Device ID	00690103190007
NIH Device Record Key	a5784b97-d793-4a6a-8846-462527214d9f
Commercial Distribution Status	In Commercial Distribution
Brand Name	THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Version Model Number	ICF100
Catalog Number	ICF100
Company DUNS	134139174
Company Name	Edwards Lifesciences LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
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	true
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

Device Dimensions

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Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103190007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132175

FDA Product Code

DXC	CLAMP, VASCULAR

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-03-21
Device Publish Date	2016-08-31

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00690103019339 - HEART VALVE ACCESSOR	2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR	2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46	2024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE	2024-10-28 FLEXIBLE HANDLE
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