TASK FORCE® MONITOR 3030i SET
Basic Information
- Brand Name
- TASK FORCE® MONITOR 3030i SET
- Primary DI
- 09120073930705
- Version / Model
- V2
- Catalog Number
- 03038
- Company Name
- CNSystems Medizintechnik AG
- Labeler DUNS
- 303562672
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-29
- Public Version
- 4
- Public Version Date
- 2019-11-20
- Public Version Status
- Update
- Public Device Record Key
- 543f4f62-c909-4e5e-92d6-f5dbe03997de
- Distribution End Date
- 2019-11-19
Device Description
Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, 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: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 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 | 09120073930705 | GS1 |
Customer Contacts
- Phone
- +4331672345633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014063 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 64.7 – 106 KiloPascal