TFM Maintenance Kit 3040i - Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, - CNSystems Medizintechnik AG

Duns Number:303562672

Device Description: Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, Eurofoam Protect, KF55B1 weiß, Zuschnitt ge Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, Eurofoam Protect, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.060_2: Pumpenlagerung Mittelteil, Eurofoam Protekt, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.060_3: Schaumstoffkleber, Foamspray 2203, 1000g Dose (für ContBP Pumpenlagerung)60_4: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung)60_5: Schwarzer, Rev 02, ContBP-Pumpe 7s52102 SP 600 EC-LC 12 V60_6: PU-Schlauch DM6/4, 100m transparent (für Pumpe 0,215 )60_7: ContBP Pumpenkabel assembliert deakon450_06: Schwarzer, 7K73051 Pumpe SP V 6TC27S RO-D 6VDC (für OszBP)450_07: Kohritsu, SV-999, Solenoid valve 6V, DC 0,6W (Hauptventil für OszBP)450_10: Zellkautschuk Stärke 6mm-7mm, schwarz, f. OszBP Pumpenlagerung, 25x25mm450_11: Moosgummi Platte Stärke 2mm, grau, f. OszBP Pumpenlagerung (6V)450_12: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung)450_13: Richmeg, RG-V-0520B, Solenoid valve (Backupventil für OszBP)

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More Product Details

Catalog Number

HHSE0004

Brand Name

TFM Maintenance Kit 3040i

Version/Model Number

V1.0

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)

-

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

7bddeb34-f8dd-4fd7-85a7-015719b031d2

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

October 27, 2016

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