EV1000 EVMB1

GUDID 00690103190229

EV1000 MONITOR BRACKET

Edwards Lifesciences LLC

Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack

• Primary Device ID: 00690103190229
• NIH Device Record Key: f785cbe7-adaa-4b51-b36b-a7f3379a42ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV1000
• Version Model Number: EVMB1
• Catalog Number: EVMB1
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103190229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160552

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-30
• Device Publish Date: 2021-09-22

On-Brand Devices [EV1000]

• 00690103193879: EV1000 NI DATABOX ADAPTOR CABL
• 00690103193626: PRESSURE CONTROLLER CUFF CONNECTOR CAP
• 00690103193619: ETHERNET CABLE 12 FT
• 00690103193602: EV1000 ETHERNET CABLE 3 FT
• 00690103193565: POWER CABLE 12 FT
• 00690103193558: POWER CABLE 3 FT
• 00690103193541: PATIENT MONITOR ADAPTOR CABLE
• 00690103193497: HEART REFERENCE SENSOR BODY PADS
• 00690103193480: PRESSURE CONTROLLER BAND
• 00690103193473: PRESSURE CONTROLLER KIT
• 00690103193374: HEART REFERENCE SENSOR
• 00690103193213: EV1000 PUMP UNIT
• 00690103191196: EV1000 POWER ADAPTOR
• 00690103191172: EV1000 POWER ADAPTOR
• 00690103190915: EV1000 POWER ADAPTOR
• 00690103190731: EV1000 POWER ADAPTOR
• 00690103190366: EV1000 ETHERNET CABLE
• 00690103190342: EV1000 FLOTRAC CABLE
• 00690103190151: EV1000 VOLUMEVIEW CABLE
• 00690103190144: EV1000 FLOTRAC CABLE
• 00690103190137: EV1000 ETHERNET CABLE
• 00690103190113: EV1000 DATABOX ASSEMBLY
• 00690103190106: EV1000 MONITOR
• 00690103189650: EV1000 PLATFORM
• 00690103190243: EV1000
• 00690103190236: EV1000 DATABOX BRACKET
• 00690103190229: EV1000 MONITOR BRACKET