Response™ 401282

GUDID 05414734200684

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

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

• Primary Device ID: 05414734200684
• NIH Device Record Key: 3d68b6ae-9c88-4f67-ac58-ba4dc20fe118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response™
• Version Model Number: JSN™
• Catalog Number: 401282
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• 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

Device Dimensions

• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734200684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894500

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-12

On-Brand Devices [Response™]

• 05414734206655: 401977
• 05414734206648: 401976
• 05414734206631: 401975
• 05414734206600: 401972
• 05414734206594: 401971
• 05414734206587: 401970
• 05414734206570: 401661
• 05414734201223: CSL™
• 05414734201209: CSL™
• 05414734201193: CSL™
• 05414734201186: CSL™
• 05414734201179: CSL™
• 05414734201100: CSL™
• 05414734201094: CSL™
• 05414734201063: CSL™
• 05414734201032: CSL™
• 05414734201018: CSL™
• 05414734200950: JSN™
• 05414734200936: JSN-1™
• 05414734200929: CRD-1™
• 05414734200899: CSL™
• 05414734200844: JSN™
• 05414734200837: CRD™
• 05414734200813: JSN™
• 05414734200806: CRD™
• 05414734200790: DAO™
• 05414734200783: JSN™
• 05414734200776: CRD™
• 05414734200769: JSN™
• 05414734200752: CRD™
• 05414734200684: JSN™
• 05414734200660: CRD™
• 05414734200646: JSN™
• 05414734200639: CRD™
• 05414734200615: JSN™
• 05414734200592: JSN™
• 05414734200585: CRD™
• 05414734200578: DAO™
• 05414734200561: JSN™
• 05414734200554: CRD™
• 05414734200523: JSN™
• 05414734200516: CRD™
• 05414734200509: DAO™
• 05414734200493: JSN
• 05414734200486: CRD™
• 05414734200462: JSN™
• 05414734200455: CRD™
• 05414734200417: CRD™
• 05414734200394: DAO-1™
• 05414734200387: JSN™