Level 1

Level 1 - D-60HL

A collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 10695085406006

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20695085406003

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20695085406003

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