| Primary Device ID | 00690103208597 | 
| NIH Device Record Key | 791b5065-5c3c-444b-84b6-866ef0fc8148 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | FORESIGHT ELITE | 
| Version Model Number | FSEO2004 | 
| Catalog Number | FSEO2004 | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| 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 | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| Length | 4 Meter | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00690103208597 [Primary] | 
| MUD | Oximeter, Tissue Saturation | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-11-18 | 
| Device Publish Date | 2021-11-10 | 
| 00690103208597 | FORESIGHT ELITE OXIMETER PREAMP CABLE, 4M | 
| 00690103219104 | PHILIPS CO TEMPERATURE PROBE 93523 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  FORESIGHT ELITE  88478862  not registered Live/Pending | Edwards Lifesciences Corporation 2019-06-18 |