FDA.report

AUTOSET

Primary DI
00619498309191
Brand
AUTOSET
Company
RESMED LIMITED
Model
30919
Catalog number
30919
Device description
AUTOSET SPIRIT FILTER 1PK
Published
2016-09-09
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

Product Codes

CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications

CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00619498309078PackageGS13In Commercial Distribution
00619498309085PackageGS150In Commercial Distribution
00619498309191PrimaryGS10

GMDN Terms

TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
800-424-0737reception@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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