| Primary Device ID | 00690103000276 |
| NIH Device Record Key | c83a4452-9a21-4d64-b0f0-72a83456a558 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SWAN-GANZ TRUE SIZE |
| Version Model Number | 111F7 |
| Catalog Number | 111F7P |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| 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 | |
| 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 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 |
| 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 |
| 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. |
| 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 | 00690103000276 [Primary] |
| GS1 | 50690103000271 [Package] Package: Shipper [5 Units] In Commercial Distribution |
| DQE | CATHETER, OXIMETER, FIBEROPTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-03 |
| 00690103197310 | SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER |
| 00690103018295 | SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F |
| 00690103017236 | SWAN-GANZ TRUE SIZE MONITORING "S" TIP CATHETER |
| 00690103000566 | SWAN-GANZ TRUE SIZE THERMODILUTION "S" TIP |
| 00690103000467 | SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER |
| 00690103000375 | SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN |
| 00690103000313 | TRUE SIZE MONITORING CATHETER TRIPLE LUMEN |
| 00690103000276 | TRUE SIZE CATHETER DOUBLE LUMEN |
| 00690103000245 | TRUE SIZE THERMODILUTION CATHETER |
| 00690103198645 | SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F |
| 00690103198638 | SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER |
| 00690103198584 | SWAN-GANZ THERMODILUTION "S" TIP |