EV1000 EVNIDBAC

GUDID 00690103193879

EV1000 NI DATABOX ADAPTOR CABL

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103193879
• NIH Device Record Key: 0c13fcdb-a89e-4ed6-961c-2b96c6d0e599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV1000
• Version Model Number: EVNIDBAC
• Catalog Number: EVNIDBAC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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(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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch
• Length: 51 Inch

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.
• 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	00690103193879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140312

FDA Product Code

• DSB: PLETHYSMOGRAPH, IMPEDANCE

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: 2018-07-06
• Device Publish Date: 2016-09-03

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