Jelco

Jelco - G1820

A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 35019517045547

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019517045543

Package Quantity: 50

Package Discontinue Date: 8/14/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Box

Device Id: 15019517045543

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: 55019517045541

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019517045547

Package Quantity: 8

Package Discontinue Date: 8/14/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case