FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304000440
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
DV56BR
Catalog number
DV56BR
Device description
SLEEPCUBE BILEVEL ST BRAZIL
Published
2016-09-23
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

Contact Domains#

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
00885304000440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304000440008853040004408853040004400885304000440

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-338-1988somdhccustomerservice@devilbisshc.com

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885304032045DeVilbiss125D-XB125D-XB2024-12-16
00885304033219DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033226DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033240DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033257DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033516DeVilbiss125D-ARYA-XB125D-ARYA-XB2025-04-28
00885304000105DeVilbiss7310P-6037310P-6032024-11-08
00885304032557DeVilbiss7325D-D-EXF7325D-D-EXF2024-11-08
00885304032571DeVilbiss7325P-D-EXF7325P-D-EXF2024-11-08
00885304001676DeVilbiss3655PL-VA3655PL-VA2016-09-08
00885304022268DeVilbiss3655I3655I-AR2017-04-21
10885304001505DeVilbiss3655PL-JCMH Case3655PL-JCMH2016-09-07
00885304020882DeVilbissDV64EDV64E2016-09-23
00885304000044DeVilbissDV54NE-PDV54NE-P2016-09-23
00885304000082DeVilbiss1751752016-09-24
00885304000884DeVilbiss5650C5650C2016-09-14
00885304022480DeVilbiss1025UK1025UK2017-08-17
00853040002806DeVilbiss9354DR9354DR2016-09-24
00853040015080DeVilbiss3655PL-JCMH3655PL-JCMH2016-09-09
00853040023382DeVilbiss7305D-D7305D-D2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07321820070060Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820072033Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820069903Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321820070008Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321822270000Vivo 1/2Breas Medical ABMNS2025-05-19
07321822280009Vivo 1/2Breas Medical ABMNS2025-05-19
00840193400276AirViewRESMED CORP.MNS2024-10-02
10850001175026ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175064ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175071ReddyPortSMD Manufacturing LLCMNS2024-01-16
00619498282852AIRCURVERESMED PTY LTDMNS2022-06-10
00840193400108AirViewRESMED CORP.MNS2021-11-30
10850001175002ReddyPortSMD Manufacturing LLCMNS2020-10-28
00606959428607DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959048720A Series, Sys One, Heater HumRespironics, Inc.MNS2020-10-16
00606959048744BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048751BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048768BiPAP A30Respironics, Inc.MNS2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2020-10-16
00606959049413BiPAP ST C Series Argentina, 30Respironics, Inc.MNS2020-10-16
00606959050938DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNS2020-10-16
00606959054691BiPAP V30 AutoRespironics, Inc.MNS2020-10-15
00606959061958A Series HumidifierRespironics, Inc.MNS2020-10-15
00606959424524DreamStationRespironics, Inc.MNS2020-09-23
00606959424869DreamStationRespironics, Inc.MNS2020-09-23
00606959424883DreamStationRespironics, Inc.MNS2020-09-23
00606959040601DreamStationRespironics, Inc.MNS2020-09-23
00606959040625DreamStationRespironics, Inc.MNS2020-09-23