Prime Series

Prime Series - 1125

Device Description

A battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Handling Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: INK

Device Name: Stretcher, Wheeled, Powered

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PM

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: 890.3690

Third Party Flag: Y

Medical Specialty: PM

Device Identifiers

Device Id: 07613327278323

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