SJM™ 406302

GUDID 15415067002997

ST. JUDE MEDICAL, INC.

Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve

• Primary Device ID: 15415067002997
• NIH Device Record Key: c4704c4f-188d-4ed6-b26e-b02ced8cfa51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• Version Model Number: 406302
• Catalog Number: 406302
• 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

• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002990 [Primary]
GS1	15415067002997 [Package]; Contains: 05415067002990; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894343

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: 2020-03-05
• Device Publish Date: 2015-09-10

On-Brand Devices [SJM™]

• 05415067027764: Monitor Cable
• 05415067027238: Connector Cable Kit
• 05415067025258: REUSABLE RF ELECTRODE
• 05415067025241: REUSABLE RF ELECTRODE
• 05415067025234: REUSABLE RF ELECTRODE
• 05415067025227: REUSABLE RF ELECTRODE
• 05415067025210: REUSABLE NITINOL RF ELECTRODE
• 05415067025203: REUSABLE NITINOL RF ELECTRODE
• 05415067025197: REUSABLE NITINOL RF ELECTRODE
• 05415067025180: REUSABLE NITINOL RF ELECTRODE
• 15415067024067: 1105
• 05415067024015: Multilead Trial Cable
• 05415067023681: 3875
• 05415067023674: 3874
• 05415067023667: DBS External Pulse Generator, 16 Channel
• 05415067023384: PW USB Receiver
• 05415067023377: AO USB Receiver
• 05415067021120: 3853
• 15415067021042: 405428
• 15415067021035: 405422
• 15415067021028: 405418
• 15415067021011: 405404
• 15415067021004: 405270
• 15415067020977: 405129
• 15415067020960: 405128
• 15415067020953: 405124
• 15415067020946: 405122
• 15415067020939: 405120
• 15415067020915: Peel Away Introducer
• 05415067019516: 1701
• 05415067019493: 1108
• 05415067019462: 1122
• 05415067019455: 1122
• 05415067019424: 1106
• 05415067018854: Nonadhesive Pouch with Belt, EPG
• 05415067018533: Adhesive Pouch, EPG
• 05415067018038: Power Supply
• 05415067017918: 3383
• 05415067017864: Epideral Needle
• 05415067017857: 1124
• 05415067017826: 1126
• 05415067017819: 1125
• 05415067017802: 1121
• 05415067017109: 1254
• 05415067016713: 2321
• 05415067016706: 2311
• 05415067016690: 2326
• 05415067016683: 2316
• 05415067016560: 3032
• 05415067016553: 3599