Product Overview

Sweatbands
NA - 0400210000


Device Description

A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: LYU

Device Name: Accessory, Surgical Apparel

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

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: 878.4040

Third Party Flag: N

Medical Specialty: SU


Device Identifiers

Device Id: 37613154272267

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613154272266

Package Quantity: 24

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack


Device Id: 07613154272266

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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