Newport Medical HT460300

GUDID 10884521541948

Air Inlet Filter Pack Assy

Covidien LP

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10884521541948
• NIH Device Record Key: d8165963-09f9-4a1c-a91d-48254e7bcaa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport Medical
• Version Model Number: HT460300
• Catalog Number: HT460300
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 5
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521541948 [Primary]
GS1	20884521657066 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111146

FDA Product Code

• CAH: Filter, bacterial, breathing-circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-26
• Device Publish Date: 2016-09-24

On-Brand Devices [Newport Medical]

• 10884521542426: REUSABLE INFANT CIRCUIT
• 10884521541948: Air Inlet Filter Pack Assy
• 10884521541382: E360 DISPOSABLE BACTERIAL FILTER X1