Astral Double Limb Kit

Primary DI: 00619498199518
Brand: Astral Double Limb Kit
Company: RESMED LIMITED
Model: 19951
Catalog number: 19951
Device description: Astral Double Limb Kit CC
Published: 2017-04-30
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

resmed.com

Product Codes

Code	Name
NOU	Continuous, Ventilator, Home Use

Product Code Classifications

Code	Device	Specialty	Class
NOU	Continuous, Ventilator, Home Use	Anesthesiology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00619498199518	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00619498199518	00619498199518	619498199518	0619498199518

GMDN Terms

Term	Definition
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).

Term

Definition

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).

Storage And Handling

Type	Low	High	Condition
Storage Environment Humidity	5 Percent (%) Relative Humidity	93 Percent (%) Relative Humidity
Storage Environment Temperature	-20 Degrees Celsius	50 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
800-427-0737	reception@resmed.com

Regulatory Flags

DUNS number: 751149311
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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