TASK FORCE® MONITOR 3040i SET
Basic Information
- Brand Name
- TASK FORCE® MONITOR 3040i SET
- Primary DI
- 09120073930637
- Version / Model
- V2
- Catalog Number
- 03141
- Company Name
- CNSystems Medizintechnik AG
- Labeler DUNS
- 303562672
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-27
- Public Version
- 4
- Public Version Date
- 2019-11-20
- Public Version Status
- Update
- Public Device Record Key
- f1fe206c-1ec9-4474-8ab5-83b3a6387af9
- Distribution End Date
- 2019-11-19
Device Description
Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61237 | Noninvasive haemodynamic monitoring system | An assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120073930637 | GS1 |
Customer Contacts
- Phone
- +4331672345633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014063 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 64.7 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius