Vital Signs
- Primary DI
- 10885403258374
- Brand
- Vital Signs
- Company
- Carefusion Finland 320 Oy
- Model
- 9446-910
- Catalog number
- 9446-910
- Device description
- Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
- Published
- 2016-10-17
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DQE | CATHETER, OXIMETER, FIBEROPTIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DQE | Catheter, Oximeter, Fiber-Optic | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10885403258374 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10885403258374 | 10885403258374 |
GMDN Terms
| Term | Definition |
|---|
| Injectate temperature probe | A non-sterile, non-patient contact device intended to be connected to a parent temperature display/monitor (not included) to measure the temperature of a vascular injectate solution (and/or injectate cooling bath) prior to its introduction into the vasculature (e.g., as part of thermodilution-based cardiac output monitoring); it is not intended to contact the injectate directly. It is typically a metal probe with a sensor and connection cable. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -22 Degrees Fahrenheit | 140 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 367919120
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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