AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single
AutoTouch reusable autoinjector - 9003600
Device Description
A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.
Environmental Conditions
- Store at room temperature
- Keep dry
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NSC
Device Name: Injector, Pen
Device Class: 2
Physical State: N/A
Definition: A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.
Submission Type ID: 1
Review Panel: HO
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: 880.5860
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 10358406470017
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00358406470010
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00358406470010
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