FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoSphere Vita
DI: 00690103217124
·
Model: HEMPC2K
·
Edwards Lifesciences LLC
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HemoSphere Vita
- Primary DI
- 00690103217124
- Version / Model
- HEMPC2K
- Catalog Number
- HEMPC2K
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 1
- Public Version Date
- 2024-03-05
- Public Version Status
- New
- Public Device Record Key
- 51696ac8-28bd-41bf-b231-810ea6a5a21d
Device Description
PRESSURE CONTROLLER KIT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 2 |
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | Cardiovascular | 870.5600 | 2 |
| DQE | Catheter, Oximeter, Fiber-Optic | Cardiovascular | 870.1230 | 2 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| QAQ | Adjunctive Predictive Cardiovascular Indicator | Cardiovascular | 870.2210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor | An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103217124 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry place