AVIVO™

GUDID 00763000065720

EXT CARDIAC AVIVO1E SEN US PHAR TUV

MEDTRONIC, INC.

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00763000065720
• NIH Device Record Key: bbe52dbb-2daf-4351-9ffb-6844201b0c20
• Commercial Distribution Discontinuation: 2018-09-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AVIVO™
• Version Model Number: AVIVO1E
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000065720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153160

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-01-06

On-Brand Devices [AVIVO™]

• 00643169651180: EXT CARDIAC MON AVIVO11 1WK KIT US
• 00763000065720: EXT CARDIAC AVIVO1E SEN US PHAR TUV
• 00763000065713: EXT CARDIAC AVIVO1T TRAN US PHAR TUV
• 00763000065706: EXT CARDIAC AVIVO11 1WK KIT US PHAR TUV