PHILIPS

Basic Information

• Brand Name: PHILIPS
• Primary DI: 00884838020429
• Version / Model: 1076374
• Catalog Number: 1076374
• Company Name: Respironics California, Inc.
• Labeler DUNS: 079550876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 2
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 241c2435-51f5-4851-85b4-e8591941c569

Device Description

Assy Battery Li-Ion,11ah,V60

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
MNT	Ventilator, continuous, minimal ventilatory support, facility use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47083	Portable electric ventilator	A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838020429	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Atmospheric Pressure, 600 to 765 mmHg
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Handling Environment Atmospheric Pressure, 600 to 765 mmHg
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, Dry, Do not put weight over 100 lbs on it. Battery must be recyced or disposed of properly