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)
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
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 71 |