Anapod Controller

GUDID 00709078001161

Anapod Controller

WESTMED, INC.

Airway temperature monitoring system Airway temperature monitoring system

• Primary Device ID: 00709078001161
• NIH Device Record Key: 665f5666-a57e-4c50-860d-467b1032d16b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anapod Controller
• Version Model Number: A2003R
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078001161 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-23

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