TFM Maintenance Kit 3040i

Basic Information

• Brand Name: TFM Maintenance Kit 3040i
• Primary DI: 09120073930491
• Version / Model: V1.0
• Catalog Number: HHSE0004
• 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: 7bddeb34-f8dd-4fd7-85a7-015719b031d2
• Distribution End Date: 2019-11-19

Device Description

Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, Eurofoam Protect, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.0 60_2: Pumpenlagerung Mittelteil, Eurofoam Protekt, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.0 60_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 V 60_6: PU-Schlauch DM6/4, 100m transparent (für Pumpe 0,215 ) 60_7: ContBP Pumpenkabel assembliert deakon 450_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, 25x25mm 450_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)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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	09120073930491	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K014063	000