Nebulizers

GUDID 10709078014403

Small Volume Nebulizer W/Adult Aerosol Mask 7' Kink Resistant Tubing Standard Connector

WESTMED, INC.

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use

• Primary Device ID: 10709078014403
• NIH Device Record Key: 19f4dfa3-c9ca-4edf-aa08-db5f8ff90e88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebulizers
• Version Model Number: 1002225
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078014406 [Primary]
GS1	10709078014403 [Package]; Contains: 00709078014406; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Nebulizers]

• 10709078014410: Small Volume Nebulizer W Pediatric Aerosol Mask 7' Kink Resistant Tubing Standard Connector
• 10709078014403: Small Volume Nebulizer W/Adult Aerosol Mask 7' Kink Resistant Tubing Standard Connector
• 10709078014397: Small Volume Nebulizer Anti-Spill T MouthpieceW/7' Kink Resistant Tubing Standard Connector
• 10709078014380: Small Volume Nebulizer Anti-Spill T W/7'Kink Resistant Tubing Standard Connector
• 10709078014373: Small Volume Nebulizer (Individual Baged) Unassembled
• 10709078014366: Small Volume Nebulizer Anti Spill T Piece Mouthpiece Flex Tube 7' Kink Resistant Tubing Standard
• 10709078014106: Small Volume Nebulizer Anti Spill T Piece Mouthpiece Flex Tube 7' Kink Resistant Tubing Universa