Product Overview

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 Identifiers

Device 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


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