UnoMist Small Volume Nebulizer

GUDID 00709078005442

WESTMED, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable

• Primary Device ID: 00709078005442
• NIH Device Record Key: 9d967ddb-e7bb-4a5f-b895-4566aee93f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UnoMist Small Volume Nebulizer
• Version Model Number: 774-E
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 300
• 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: true
• Serial Number: false
• 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	00709078005442 [Primary]
GS1	00709078005459 [Unit of Use]

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

Devices Manufactured by WESTMED, INC.

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• 10709078007665 - Uni-Lim Coaxial Circuit: 2024-02-15 Uni-Lim Coaxial Circuit 48" Expandable Anesthesia Extension Kit
• 30889483608955 - Anesthesia Circuit Kit: 2023-12-28 96" flexible dual limb | patient elbow with sampling port parallel wye | in-line mini HMEF with sample port large adult mask | M
• 30889483608962 - Anesthesia Circuit Kit: 2023-12-28 120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L la
• 30889483608979 - Anesthesia Circuit Kit: 2023-12-28 60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L late
• 30889483608986 - Anesthesia Circuit Kit: 2023-12-28 60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1
• 30889483608993 - Anesthesia Circuit Kit: 2023-12-28 72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 2L late
• 30889483609006 - Anesthesia Circuit Kit: 2023-12-28 120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1