Replacement Cabel for ANAPOD

GUDID 00709078006012

Replacement Cabel for ANAPOD

WESTMED, INC.

Airway temperature monitoring system

• Primary Device ID: 00709078006012
• NIH Device Record Key: a2db4699-04e9-40ae-b31e-d532e5534486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Replacement Cabel for ANAPOD
• Version Model Number: A4072
• 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: false
• 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	00709078006012 [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: 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.

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• 20889483612016 - Anesthesia Circuit Kit: 2024-06-10 60" Adult Anes. Circuit; Par-Wye, GSE, 2L Latex Free
• 20889483612023 - Anesthesia Circuit Kit: 2024-06-10 60" Pediatric Anes. Circuit, Par-Wye, GSE W/Port
• 20889483612030 - Anesthesia Circuit Kit: 2024-06-10 UniLim,120" Adult.Coa.Circuit,Elbow,24Flex Expiratory
• 20889483612047 - Anesthesia Circuit Kit: 2024-06-10 UniLim,72" Adult.Coa.Cir,GSE,24Flex Expiratory
• 20889483612054 - Anesthesia Circuit Kit: 2024-06-10 96" Adult Exp.Anes.Circuit,Par-Wye,GSE W/Cap