FDA.report

LUMIS

Primary DI
00619498282197
Brand
LUMIS
Company
RESMED LIMITED
Model
150
Catalog number
28219
Device description
LUMIS VPAP ST-A 3G
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNSVentilator, Continuous, Non-Life-Supporting

Product Code Classifications

CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00619498282197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498282197006194982821976194982821970619498282197

GMDN Terms

TermDefinition
Home BPAP 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 bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 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
true
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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00619498394203AIR 1139300393002021-03-31
00619498391004HUMIDAIR11 STANDARD39100391002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498392056AIR 1139205392052021-03-31
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00619498393008AIR 1139300393002021-03-31
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10850001175026ReddyPortSMD Manufacturing LLCMNS2024-01-16
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