Newport Medical

GUDID 10884521544444

KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4

Newport Medical Instruments, Inc.

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• Primary Device ID: 10884521544444
• NIH Device Record Key: 0a915ddd-25f9-49a8-a1d7-ddb352ca3e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport Medical
• Version Model Number: KIT3420A
• Company DUNS: 050334275
• Company Name: Newport Medical Instruments, 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521544444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111146

FDA Product Code

• CBK: Ventilator, continuous, facility use

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: 2021-10-12
• Device Publish Date: 2021-10-04

On-Brand Devices [Newport Medical]

• 10884521649934: Permanent Adult/Ped Circuit W/O Water Trap and Exhalation Valve
• 10884521542471: REUSABLE PED CIRCUIT W/O PROX
• 10884521542440: REUSABLE INFANT CIRCUIT W/PROX
• 10884521542402: REUSABLE ADULT CIRCUIT W/O PRO
• 10884521542013: REUSBLE 15MM CCT, W/WT
• 10884521541993: REUSBLE 22MM CCT, W/WT
• 10884521541986: PED-ADLT REUSBLE NT CCT W/EXHV
• 10884521541979: PED-ADLT REUSBLE NT CCT W/EXHV
• 10884521644700: Universal (22mm ID) Ventilation Breathing Circuit Without Water Trap
• 20884521540511: Pediatric (15 mm ID) Abbreviated (Partical) J Ventilation Breathing Circuit
• 10884521644717: Universal (22 mm ID) J Ventilation Breathing Circuit
• 20884521540641: 180"" Universal (22 mm ID) J Ventilation Breathing Circuit Without Water Trap
• 10884521644694: Universal (22 mm ID) Abbreviated (Partial) J Ventilation Breathing Circuit
• 10884521644687: Universal Ventilation Breathing Circuit
• 10884521644670: Universal (22 mm ID) J Ventilation Breathing Circuit
• 20884521540542: 180"" Pediatric (15 mm ID) J Ventilation Breathing Circuit Without Water Trap
• 10884521644663: Pediatric Ventilation Breathing Circuit
• 10884521541399: Filter, Bacteria
• 10884521511903: E360 VENTILATOR WITH ACCESSORIES S MODEL
• 10884521541467: Filters
• 10884521542389: Oxygen Analyzer
• 10884521649941: Perm. 15MM/Ped Circuit W/O Water Trap and Exhalation Valve
• 10884521542396: REUSBLE ADLT CCT W/PROX, HTD W
• 10884521544444: KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4
• 10884521542037: PROXIMAL INLINE FILTER PK OF 5
• 10884521542617: Medical Oxygen Sensor
• 10884521542464: REUSABLE INFANT CIRCUIT W/O PR