FlexAbility™ A701125

GUDID 05415067011114

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

Primary Device ID	05415067011114
NIH Device Record Key	bd6cffa8-a347-4ac3-acb1-0fb96fb169de
Commercial Distribution Status	In Commercial Distribution
Brand Name	FlexAbility™
Version Model Number	A701125
Catalog Number	A701125
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, 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.
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	05415067011114 [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
FLEXABILITY 90801514 not registered Live/Pending	MHO, LLC 2021-06-29
FLEXABILITY 90801492 not registered Live/Pending	MHO, LLC 2021-06-29
FLEXABILITY 90801390 not registered Live/Pending	MHO, LLC 2021-06-29
FLEXABILITY 85930896 4615376 Live/Registered	St. Jude Medical, Inc., Atrial Fibrillation Division, Inc. 2013-05-13
FLEXABILITY 78886671 not registered Dead/Abandoned	RZN Nutraceuticals, Inc. 2006-05-18
FLEXABILITY 77285937 3511057 Dead/Cancelled	Coalition Computing Corp. 2007-09-21
FLEXABILITY 76603008 not registered Dead/Abandoned	Coalition Computing, Inc. 2004-07-20
FLEXABILITY 76418333 not registered Dead/Abandoned	Coalition Computing, Inc. 2002-05-30
FLEXABILITY 75437965 not registered Dead/Abandoned	Flexalloy Inc. 1998-02-20