EV1000 EV1000DB
GUDID 00690103190113
EV1000 DATABOX ASSEMBLY
Edwards Lifesciences LLC
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 | 00690103190113 |
| NIH Device Record Key | 7dde6139-5334-4271-8473-8f21fdaacc46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EV1000 |
| Version Model Number | EV1000DB |
| Catalog Number | EV1000DB |
| 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 | 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)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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. |
| 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 | 00690103190113 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131892
FDA Product Code
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| 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 |
Trademark Results [EV1000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EV1000 77691071 3998619 Live/Registered |
Edwards Lifesciences Corporation 2009-03-13 |
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