Level 1 - F-30
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: KZL
Device Name: Device, Warming. Blood And Plasma
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.9205
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 10695085433002
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 30695085433006
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 30695085433006
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: 20695085433009
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085433002
Package Quantity: 80
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX