- Physicians Office Resource

Level 1 - PF-1

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: True

Sterilization Methods:

Ethylene Oxide

Ethylene Oxide

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: 30695085400107

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10695085400103

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Pallet

Device Id: 10695085400103

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20695085400100

Package Quantity: 60

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20695085400100

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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