FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304007425
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
DV56I-670
Device description
Part Sleep Flow Generator Accessories Product Description SLEEP CASE REPAIR KIT
Published
2020-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNSVentilator, continuous, non-life-supporting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304007425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304007425008853040074258853040074250885304007425

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
962175894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885304032502DeVilbiss125K-XB2020-05-27
03664390148857DeVilbissMQ5890-EU2020-05-21
00885304003816DeVilbissEX3000D-6522021-04-16
00822384002025DeVilbissDV54SE2020-04-03
00885304000280DeVilbiss9354DR2020-04-03
00885304000822DeVilbiss3655LTPL-REL2020-04-03
00885304000990DeVilbiss7310PD-PS2020-04-03
00885304001164DeVilbissDV51D-HH-S2020-04-03
00885304001508DeVilbiss3655PL-JCMH2020-04-03
00885304002338DeVilbiss7305D-D2020-04-03
00885304002598DeVilbiss535D-C-CF-RE2020-04-03
00885304002635DeVilbiss535D-E-8702020-04-03
00885304002970DeVilbissPD1000A-ML6-RE2020-04-03
00885304008798DeVilbissDV57D-HH-S-HT2020-04-03
00885304022473DeVilbiss1025KS2020-04-03
00885304007142DeVilbiss3655D-6032020-02-11
00885304007197DeVilbissPD1000D-6072020-02-11
00885304007463DeVilbissDV5C-6012020-02-11
00885304006763DeVilbissDV5C-6142020-02-10
00885304002482DeVilbiss5650D-6012020-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049840Care OrchestratorRespironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNS2020-05-20
00606959053519DreamMapper Web (EMEA)Respironics, Inc.MNS2020-05-20
00885304006756DeVilbissDEVILBISS HEALTHCARE LLCMNS2020-02-07
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959049871DreamMapper Web (APAC)Respironics, Inc.MNS2019-04-19
00606959049925DreamMapper Android China Instance v 2.11Respironics, Inc.MNS2019-04-19
00606959049888DreamMapper Web China Instance v 2.11Respironics, Inc.MNS2019-04-18
00606959049895DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2019-04-18
00606959049901DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2019-04-18
00606959049918DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2019-04-18
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959054820EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959053984Care Orchestrator EssenceRespironics, Inc.MNS2018-12-20
00606959054790Care OrchestratorRespironics, Inc.MNS2018-12-10
00606959054189DreamMapperRespironics, Inc.MNS2018-10-30
00606959054196DreamMapperRespironics, Inc.MNS2018-10-30
00606959054202DreamMapperRespironics, Inc.MNS2018-10-30
00606959054219DreamMapperRespironics, Inc.MNS2018-10-30
00606959054226DreamMapperRespironics, Inc.MNS2018-10-30