Disposable Respiratory Products, Neo-Pod T

GUDID 00709078006005

Universal Neonatal Transport Circuit with Lavabed

WESTMED, INC.

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

• Primary Device ID: 00709078006005
• NIH Device Record Key: 449532d2-0e20-4e1b-afb0-6eef4b483e9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Respiratory Products, Neo-Pod T
• Version Model Number: 9402U
• 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: 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	00709078006005 [Primary]
GS1	10709078006002 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870173

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (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: 2018-10-26
• Device Publish Date: 2018-09-25

Devices Manufactured by WESTMED, INC.

• 10709078006200 - Anesthesia Circuit Kit: 2024-02-15 96" expandable dual limb circuit patient elbow with capped sampling port in-line mini HMEF with sample port Size 6 large adult m
• 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