Ultimum™ 407653

GUDID 15414734009406

ST. JUDE MEDICAL, INC.

Vascular catheter introduction set, nonimplantable

Primary Device ID	15414734009406
NIH Device Record Key	5e2df061-6862-4473-af08-a13d42b8a1c7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ultimum™
Version Model Number	EV
Catalog Number	407653
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

Device Dimensions

Length	12 Centimeter
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter
Catheter Gauge	10 French
Length	12 Centimeter

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734009409 [Primary]
GS1	15414734009406 [Package] Contains: 05414734009409 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K023447

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	2019-06-07
Device Publish Date	2015-08-31

On-Brand Devices [Ultimum™]

05415067014382	EV
05415067009692	EV
15415067000740	407692
15414734054772	407696
15414734054758	407695
15414734054734	407694
15414734054710	407693
05414734027991	HEMOSTASIS INTRODUCER
05414734027717	EV
15414734025697	C407595
15414734025680	C407599
15414734025659	C407594
15414734025598	C407597
15414734025567	C407598
05414734021999	EV
05414734021968	EV
05414734020930	EV
15414734016237	407861
15414734016213	407860
15414734016190	407859
15414734016176	407858
15414734016152	407857
15414734016138	407856
15414734016114	407855
15414734016091	407854
15414734016077	407853
15414734016053	407852
15414734016039	407841
15414734016015	407840
15414734015995	407836
15414734015971	407834
15414734015957	407833
15414734015933	407830
15414734013045	EV
15414734013021	407842
15414734011454	HEMOSTASIS INTRODUCER
15414734011430	EV
15414734011416	HEMOSTASIS INTRODUCER
15414734011393	HEMOSTASIS INTRODUCER
15414734011379	EV
15414734011355	EV
15414734011331	HEMOSTASIS INTRODUCER
15414734011317	HEMOSTASIS INTRODUCER
15414734011294	EV
15414734011270	EV
15414734011256	EV
15414734011232	EV
15414734011218	EV
15414734011195	EV
15414734011171	EV

Trademark Results [Ultimum]

Mark Image Registration \| Serial	Company Trademark Application Date
ULTIMUM 88775991 not registered Live/Pending	Meyer Manufacturing Company Limited 2020-01-28
ULTIMUM 87701773 not registered Dead/Abandoned	Raynal Roberto Armando 2017-11-29
ULTIMUM 87701711 not registered Dead/Abandoned	Armando Roberto Raynal 2017-11-29
ULTIMUM 86951374 not registered Dead/Abandoned	Meyer Manufacturing Company Limited 2016-03-24
ULTIMUM 85956500 4466327 Live/Registered	BEC Technologies, Inc 2013-06-11
ULTIMUM 75271340 2290421 Dead/Cancelled	LEINER HEARLTH SERVICES CORP. 1997-04-08