enableCV Percutaneous Insertion Kit-Arterial PIKA5

GUDID 00840479401003

Percutaneous Insertion Kit-Arterial

ENABLECV INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00840479401003
NIH Device Record Keya9454678-9166-4b97-8f85-7771e7f03fad
Commercial Distribution StatusIn Commercial Distribution
Brand NameenableCV Percutaneous Insertion Kit-Arterial
Version Model NumberPIKA5
Catalog NumberPIKA5
Company DUNS119247843
Company NameENABLECV INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com
Phone1(888)943-2783
Emailcustomerservice@enablecv.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile package in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840479400990 [Primary]
GS100840479401003 [Package]
Contains: 00840479400990
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-08
Device Publish Date2025-12-31

Devices Manufactured by ENABLECV INC.

00840479400907 - enableCV Percutaneous Insertion Kit-Venous2026-01-08 Percutaneous Insertion Kit-Venous
00840479401003 - enableCV Percutaneous Insertion Kit-Arterial2026-01-08Percutaneous Insertion Kit-Arterial
00840479401003 - enableCV Percutaneous Insertion Kit-Arterial2026-01-08 Percutaneous Insertion Kit-Arterial
00840479402161 - enableCV QuickDraw™ Plus Venous Cannula2026-01-08 QuickDraw™ Plus Venous Cannula
00840479400013 - enableCV ProPlege Peripheral Retrograde Cardioplegia Device2025-04-17 ProPlege Peripheral Retrograde Cardioplegia Device

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