Cool Path™ A700241

GUDID 05415067002419

Cardiac mapping/radio-frequency ablation catheter, single-use

Primary Device ID	05415067002419
NIH Device Record Key	0907b983-ca75-4af5-84f8-c856d6e6cb69
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cool Path™
Version Model Number	Duo, MediGuide Enabled™
Catalog Number	A700241
Company DUNS	926346966
Company Name	IRVINE BIOMEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry location.

Device Issuing Agency	Device ID
GS1	05415067002419 [Primary]

OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Steralize Prior To Use	false
Device Is Sterile	true

Mark Image Registration \| Serial	Company Trademark Application Date
COOL PATH 85160408 3974533 Live/Registered	St. Jude Medical, Atrial Fibrillation Division, Inc. 2010-10-25