Newport Medical HT6004701

GUDID 10884521542037

PROXIMAL INLINE FILTER PK OF 5

Newport Medical Instruments, Inc.

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10884521542037
• NIH Device Record Key: f93202f7-74d2-4ded-bc09-aa38a1421b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport Medical
• Version Model Number: HT6004701
• Catalog Number: HT6004701
• Company DUNS: 050334275
• Company Name: Newport Medical Instruments, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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
• 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 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521542037 [Primary]
GS1	20884521542034 [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: 2
• Public Version Date: 2021-12-22
• Device Publish Date: 2019-02-09

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