Level 1 - SC-3
Device Description
A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. 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: 30695085400305
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20695085400308
Package Quantity: 160
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20695085400308
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085400301
Package Quantity: 40
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10695085400301
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 40695085400302
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 40695085400302
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