Level 1 - YC-8
Device Description
A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LGZ
Device Name: Warmer, Thermal, Infusion Fluid
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: 880.5725
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 20695085403804
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085403807
Package Quantity: 40
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10695085403807
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 40695085403808
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 40695085403808
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: 30695085403801
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20695085403804
Package Quantity: 160
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
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