Calculating Cuff Inflator
Hokanson - TD312DL
Device Description
A hand-held, battery-powered device intended to be used by a healthcare professional in a clinical setting to enable manually-controlled powered inflation of a blood pressure cuff; it may also be intended to store pressure values. It consists of a compact unit with an electronic pump, internal pressure sensor, pressure display, controls, and tubing to connect to the cuff; the cuff is not included. It is intended to be used with a separate blood flow sensor (e.g., Doppler ultrasound or plethysmograph), to allow measurement of blood pressure; it is not intended for rapid cuff inflation.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXN
Device Name: System, Measurement, Blood-Pressure, Non-Invasive
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1130
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00817065021402
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A