TASK FORCE® MONITOR 3040i SET - Type 3040i , SET of: 09120073930644, TASK FORCE® - CNSystems Medizintechnik AG

Duns Number:303562672

Device Description: Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP)09120073 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" connector09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad09120073930675, 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 connector09120073930562, 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-1545010840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8mElectric supply wire, 3m,Interpower, grounded plug09120073930590, Instruction manual English USA04046938268248, Arm sling

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More Product Details

Catalog Number

03141

Brand Name

TASK FORCE® MONITOR 3040i SET

Version/Model Number

V2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K014063

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

224c1822-c90e-4a41-8385-55444066c4d2

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

June 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CNSYSTEMS MEDIZINTECHNIK AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 71