| Primary Device ID | 00690103151961 |
| NIH Device Record Key | cf5f732b-b335-4fde-a872-46321808ef0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SWAN-GANZ PACEPORT |
| Version Model Number | 991F8 |
| Catalog Number | 991F8 |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 00690103151961 [Primary] |
| KRA | Catheter, continuous flush |
| 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 |
| 00690103197341 | SWAN-GANZ PACEPORT OXIMETRY TD CATHETER |
| 00690103151961 | SWAN-GANZ THERMODILUTION A-V PACEPORT CATHETER |
| 00690103003925 | SWAN-GANZ THERMODILUTION PACEPORT CATHETER |