Adstation Oto+-L/Coax+Oph-L,Derm/Clock Aner

Adstation Oto+
Diagnostix™ - 56802L-57

A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DXQ

Device Name: Blood Pressure Cuff

Device Class: 2

Physical State: N/A

Definition: A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

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: 870.1120

Third Party Flag: Y

Medical Specialty: CV

Code: ERA

Device Name: Otoscope

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: EN

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: 874.4770

Third Party Flag: N

Medical Specialty: EN

Code: HLJ

Device Name: Ophthalmoscope, Battery-Powered

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: OP

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: 886.1570

Third Party Flag: N

Medical Specialty: OP

Code: IBJ

Device Name: Light, Microscope

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.3600

Third Party Flag: N

Medical Specialty: PA

Device Id: 00634782089719

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