Level 1

Level 1 - H-31-ES

A mains electricity (AC-powered) device that is typically a module or a component of a high-flow blood/fluid warmer, and that provides an alarm and/or stops the flow of fluid when it detects air or foam in the de-aeration chamber of the blood/fluid warming set and/or when the fluid level in the de-aeration chamber is too low.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BSB

Device Name: Warmer, Blood, Non-Electromagnetic Radiation

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: 50695085002930

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