Level 1 - L-10
Device Description
A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. 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: 30695085401005
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20695085401008
Package Quantity: 160
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20695085401008
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085401001
Package Quantity: 40
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10695085401001
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 40695085401002
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 40695085401002
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