Newport

Basic Information

• Brand Name: Newport
• Primary DI: 10884521544307
• Version / Model: HT70PM-ES-NA
• Company Name: Newport Medical Instruments, Inc.
• Labeler DUNS: 050334275
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-31
• Public Version: 6
• Public Version Date: 2022-05-25
• Public Version Status: Update
• Public Device Record Key: 0012bc05-9452-455d-9e00-fc0e335f6433

Device Description

HT70 Ventilator with Accessories Plus Model

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	VENTILATOR, CONTINUOUS, FACILITY USE	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42411	Neonatal/adult intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521544307	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111146	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .5 – 1.06 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, Keep dry, This side up
• Type: Handling Environment Temperature
• Temperature Range: -18 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .6 – 1.1 KiloPascal