FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304020868
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
DV63E
Catalog number
DV63E
Device description
IntelliPAP 2 Standard Plus CPAP - EUROPE
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304009061PackageGS11Not in Commercial Distribution
00885304009078PackageGS11Not in Commercial Distribution
00885304009085PackageGS11Not in Commercial Distribution
00885304009092PackageGS11Not in Commercial Distribution
00885304009108PackageGS11Not in Commercial Distribution
00885304009115PackageGS11Not in Commercial Distribution
00885304009122PackageGS11Not in Commercial Distribution
00885304009139PackageGS11Not in Commercial Distribution
00885304009146PackageGS11Not in Commercial Distribution
00885304009153PackageGS11Not in Commercial Distribution
00885304009160PackageGS11Not in Commercial Distribution
00885304009177PackageGS11Not in Commercial Distribution
00885304009184PackageGS11Not in Commercial Distribution
00885304009191PackageGS11Not in Commercial Distribution
00885304009207PackageGS11Not in Commercial Distribution
00885304009214PackageGS11Not in Commercial Distribution
00885304009221PackageGS11Not in Commercial Distribution
00885304009238PackageGS11Not in Commercial Distribution
00885304020868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304009061008853040090618853040090610885304009061
00885304009078008853040090788853040090780885304009078
00885304009085008853040090858853040090850885304009085
00885304009092008853040090928853040090920885304009092
00885304009108008853040091088853040091080885304009108
00885304009115008853040091158853040091150885304009115
00885304009122008853040091228853040091220885304009122
00885304009139008853040091398853040091390885304009139
00885304009146008853040091468853040091460885304009146
00885304009153008853040091538853040091530885304009153
00885304009160008853040091608853040091600885304009160
00885304009177008853040091778853040091770885304009177
00885304009184008853040091848853040091840885304009184
00885304009191008853040091918853040091910885304009191
00885304009207008853040092078853040092070885304009207
00885304009214008853040092148853040092140885304009214
00885304009221008853040092218853040092210885304009221
00885304009238008853040092388853040092380885304009238
00885304020868008853040208688853040208680885304020868

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.

Contacts#

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

Regulatory Flags#

DUNS number
962175894
Device count
1
Serial number
true

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

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