ICU Medical
- Primary DI
- 10840619030084
- Brand
- ICU Medical
- Company
- ICU MEDICAL, INC.
- Model
- 50472
- Catalog number
- 50472-01
- Device description
- TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated
- Published
- 2021-08-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| DQE | Catheter, oximeter, fiber-optic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DQE | Catheter, Oximeter, Fiber-Optic | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10840619030084 | Package | GS1 | 10 | In Commercial Distribution |
| 00840619030087 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10840619030084 | 10840619030084 | | |
| 00840619030087 | 00840619030087 | 840619030087 | 0840619030087 |
GMDN Terms
| Term | Definition |
|---|
| Pulmonary artery balloon catheter, oximetric | A flexible tube with an inflatable balloon at its distal tip designed for measuring pulmonary arterial pressures and mixed venous oxygen saturation (SvO2) levels when connected to an appropriate oximetric patient monitor; it may also measure pulmonary artery wedge pressure. It uses a fibreoptic bundle and light-emitting diodes (LEDs) which using light emitted at two or three different wavelengths (e.g., red or near infrared) from the catheter and reflected back from the red blood cells provide the measurements. It is used in emergencies, for monitoring critically ill patients (e.g., acute respiratory failure, severe head injury) and during surgical procedures. This is a single-use device. |
Regulatory Flags
- DUNS number
- 118380146
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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|---|
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| 10840619046610 | ICU Medical | ICU MEDICAL, INC. | DQE | 2025-03-25 |
| 00690103217957 | HemoSphere Alta | Edwards Lifesciences LLC | DQE | 2025-03-13 |
| 00690103217964 | HemoSphere Alta | Edwards Lifesciences LLC | DQE | 2025-03-13 |
| 00690103217971 | HemoSphere Alta | Edwards Lifesciences LLC | DQE | 2025-03-13 |
| 00690103219289 | SWAN GANZ | Edwards Lifesciences LLC | DQE | 2024-08-30 |
| 50690103219376 | SWAN GANZ | Edwards Lifesciences LLC | DQE | 2024-08-30 |
| 50690103219383 | SWAN-GANZ | Edwards Lifesciences LLC | DQE | 2024-08-05 |
| 10840619030091 | ICU Medical | ICU MEDICAL, INC. | DQE | 2022-10-04 |
| 10840619030114 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
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| 10840619041875 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619041967 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043565 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043572 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043596 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043619 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043657 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043671 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043688 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043695 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043701 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043732 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |
| 10840619043756 | ICU Medical | ICU MEDICAL, INC. | DQE | 2021-08-29 |