Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.
Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's - 278030
Device Description
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 8 Millimeter
- Needle Gauge: 30 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMI
Device Name: Needle, Hypodermic, Single Lumen
Device Class: 2
Physical State: N/A
Definition: N/A
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: 880.5570
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 00015482280307
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
Device Id: 50015482280302
Device Type: Unit of Use
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