Ultimum™ 407692

GUDID 15415067000740

ST. JUDE MEDICAL, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 15415067000740
• NIH Device Record Key: 3887aad6-d8d8-4f17-aed2-5eaf446346a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimum™
• Version Model Number: 407692
• Catalog Number: 407692
• 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

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 French
• Length: 26 Centimeter
• Catheter Gauge: 6 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067000743 [Primary]
GS1	15415067000740 [Package]; Contains: 05415067000743; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001346

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: 2015-09-09

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