Engage™ C408521

GUDID 15414734053195

ST. JUDE MEDICAL, INC.

Vascular catheter introduction set, nonimplantable

Primary Device ID	15414734053195
NIH Device Record Key	a9ac4bd0-1981-4fdc-a4d4-e22cb037a75b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Engage™
Version Model Number	C408521
Catalog Number	C408521
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, INC.
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	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

Customer Support Contacts

Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com

Device Dimensions

Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734053198 [Primary]
GS1	15414734053195 [Package] Contains: 05414734053198 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111092

FDA Product Code

DYB	INTRODUCER, CATHETER

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	2019-07-08
Device Publish Date	2015-04-11

On-Brand Devices [Engage™]

15414734055946	TR
15414734055922	TR
15414734055908	TR
15414734055885	TR
15414734055861	TR
15414734055847	TR
15414734053553	TR
15414734053539	TR
15414734053195	C408521
15414734053171	C408510
15414734053157	C408516
15414734053133	C408505
15414734053119	C408520
15414734053096	C408519
15414734053058	C408517
15414734053034	C408509
15414734053010	C408508
15414734052976	C408506
15414734052952	C408515
15414734052938	C408514
15414734052914	C408513
15414734052891	C408512
15414734052877	C408511
15414734052853	C408504
15414734052839	C408503
15414734052815	C408502
15414734052792	C408501
15414734052778	C408500
15414734052754	TR
15414734052730	TR
15414734052716	TR
15414734052693	TR
15414734052631	TR
15414734052617	TR
15414734052594	TR
15414734052570	Introducer
15414734030486	C408518
15414734030462	C408507
15414734030448	TR
15414734030400	TR
05414734055949	Introducer; 6F-ACT
05414734055925	Introducer, 5F-ACT
05414734055901	Introducer; 4F-ACT
05414734055888	Introducer; 6F-ACT
05414734055864	Introducer; 5F-ACT
05414734055840	Introducer; 4F-ACT
05414734053556	Introducer; 6F-ACT
05414734053532	Introducer; 6F-ACT
05414734053174	Introducer; 9F-ACT
05414734052757	Introducer; 5F-ACT

Trademark Results [Engage]

Mark Image Registration \| Serial	Company Trademark Application Date
ENGAGE 98716782 not registered Live/Pending	A. O. Smith Corporation 2024-08-26
ENGAGE 98703891 not registered Live/Pending	PowerDMS, Inc. 2024-08-18
ENGAGE 98455222 not registered Live/Pending	LOOP BV 2024-03-18
ENGAGE 98439227 not registered Live/Pending	Michael Pollak 2024-03-07
ENGAGE 98411909 not registered Live/Pending	COMPUTER SOFTWARE & SOLUTIONS INTERNATIONAL, LLC 2024-02-20
ENGAGE 98360687 not registered Live/Pending	Prime Research Solutions LLC 2024-01-17
ENGAGE 98287091 not registered Live/Pending	Blumenthal Distributing, Inc. 2023-11-27
ENGAGE 98247762 not registered Live/Pending	Prime Research Solutions LLC 2023-10-31
ENGAGE 98172965 not registered Live/Pending	ASSESSMENT TECHNOLOGIES INSTITUTE, L.L.C. 2023-09-10
ENGAGE 98160720 not registered Live/Pending	Williams Lea Group Limited 2023-09-01
ENGAGE 98137932 not registered Live/Pending	Aristocrat Technologies, Inc. 2023-08-17
ENGAGE 98033826 not registered Live/Pending	Vino del Sol, Inc. 2023-06-08