1 mL TB 25 Ga. x 5/8 in. Detachable Needle
Omnifix™ - 9161422-02
Device Description
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Total Volume: 1.0 Milliliter
- Gauge (cannula) : 25
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
Code: FMF
Device Name: Syringe, Piston
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: 880.5860
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 04046963452414
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04046963452407
Package Quantity: 16
Package Discontinue Date: 4/4/2020 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Carton
Device Id: 04046963452407
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: 04046964354373
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