FDA.report

Stellar

Primary DI
00619498249336
Brand
Stellar
Company
RESMED LIMITED
Model
24933
Catalog number
24933
Device description
Hypoallergen Filter 1 pk
Published
2015-12-22
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

Product Codes

CodeName
MNTVentilator, Continuous, Minimal Ventilatory Support,Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00619498249336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498249336006194982493366194982493360619498249336

GMDN Terms

TermDefinition
Portable electric ventilatorA 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

TypeLowHighCondition
Storage Environment Humidity10 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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