SJM™ C12781

GUDID 05415067023384

PW USB Receiver

ST. JUDE MEDICAL, INC.

Medical networking interface unit

• Primary Device ID: 05415067023384
• NIH Device Record Key: 26cdabab-eb47-492d-9bef-2d89018ddc40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• Version Model Number: PW USB Receiver
• Catalog Number: C12781
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 113 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067023384 [Primary]

FDA Product Code

• DRG: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2016-06-14

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• 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
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• 05415067018854: Nonadhesive Pouch with Belt, EPG
• 05415067018533: Adhesive Pouch, EPG
• 05415067018038: Power Supply
• 05415067017918: 3383
• 05415067017864: Epideral Needle
• 05415067017857: 1124
• 05415067017826: 1126
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