SWAN-GANZ TRUE SIZE
- Primary DI
- 00690103218602
- Brand
- SWAN-GANZ TRUE SIZE
- Company
- Edwards Lifesciences LLC
- Model
- 096F6
- Catalog number
- 096F6P
- Device description
- TRUE SIZE THERMODILUTION CATHETER
- Published
- 2026-03-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
Product Code Classifications#
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K160084 | 000 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016-05-03 | DYG |
| K231248 | 000 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | 2023-09-21 | DYG |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 50690103218607 | Package | GS1 | 5 | In Commercial Distribution |
| 00690103218602 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 50690103218607 | 50690103218607 | ||
| 00690103218602 | 00690103218602 | 690103218602 | 0690103218602 |
GMDN Terms#
| Term | Definition |
|---|---|
| Pulmonary artery balloon catheter, electrical | A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | STORE IN A COOL, DRY PLACE. |
Contacts#
| Phone | |
|---|---|
| +1(800)822-9637 | tech_support@edwards.com |
Regulatory Flags#
- DUNS number
- 134139174
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Contains natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00690103019643 | HEART VALVE ACCESSORY | 1170 | 117019MM | 2026-04-06 |
| 00690103019650 | HEART VALVE ACCESSORY | 1170 | 117021MM | 2026-04-06 |
| 00690103019674 | HEART VALVE ACCESSORY | 1170 | 117025MM | 2026-04-06 |
| 00690103019698 | HEART VALVE ACCESSORY | 1170 | 117029MM | 2026-04-06 |
| 00690103019704 | HEART VALVE ACCESSORY | 1174M | 1174M24 | 2026-04-06 |
| 00690103019711 | HEART VALVE ACCESSORY | 1174M | 1174M26 | 2026-04-06 |
| 00690103019728 | HEART VALVE ACCESSORY | 1174M | 1174M28 | 2026-04-06 |
| 00690103019735 | HEART VALVE ACCESSORY | 1174M | 1174M30 | 2026-04-06 |
| 00690103019742 | HEART VALVE ACCESSORY | 1174M | 1174M32 | 2026-04-06 |
| 00690103019759 | HEART VALVE ACCESSORY | 1174M | 1174M34 | 2026-04-06 |
| 00690103019766 | HEART VALVE ACCESSORY | 1174M | 1174M36 | 2026-04-06 |
| 00690103019773 | HEART VALVE ACCESSORY | 1174M | 1174M38 | 2026-04-06 |
| 00690103019780 | HEART VALVE ACCESSORY | 1174M | 1174M40 | 2026-04-06 |
| 00690103019797 | HEART VALVE ACCESSORY | 1175T | 1175T26 | 2026-04-06 |
| 00690103019803 | HEART VALVE ACCESSORY | 1175T | 1175T28 | 2026-04-06 |
| 00690103019810 | HEART VALVE ACCESSORY | 1175T | 1175T30 | 2026-04-06 |
| 00690103019827 | HEART VALVE ACCESSORY | 1175T | 1175T32 | 2026-04-06 |
| 00690103019834 | HEART VALVE ACCESSORY | 1175T | 1175T34 | 2026-04-06 |
| 00690103019841 | HEART VALVE ACCESSORY | 1175T | 1175T36 | 2026-04-06 |
| 00690103019858 | HEART VALVE ACCESSORY | 1175T | 1175T38 | 2026-04-06 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G4533352797GM8M50 | PEAK MEDICAL | Peak Medical Distribution Inc. | KRA | 2026-05-27 |
| 07640132622690 | M-CATH Flexy | Acrostak (Schweiz) AG | KRA | 2021-11-01 |
| 07640132622706 | M-CATH Flexy | Acrostak (Schweiz) AG | KRA | 2021-11-01 |
| 07613327313956 | Trevo Trak 21 | Stryker Corporation | DQO | 2020-04-17 |
| 07640132622157 | M-CATH Microcatheter | Acrostak (Schweiz) AG | KRA | 2018-05-15 |
| 08714729152989 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729188865 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729200291 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213161 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213178 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213185 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213192 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213208 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213369 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213666 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213741 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213888 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213918 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214007 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214083 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214120 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214168 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214243 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214342 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214380 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214441 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214472 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214502 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214632 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214656 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |