FDA.report

RPSII

Primary DI
00619498249596
Brand
RPSII
Company
RESMED LIMITED
Model
24959
Catalog number
24959
Device description
RPSII DC CABLE VPAP III, STELLAR
Published
2016-09-29
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
00619498249596PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00619498249596140061949824959606194982495960619498249596Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

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 Atmospheric Pressure68 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

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
false
Serial number
false
Manufacturing date on label
true
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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