FDA.reportPublic FDA data

PHILIPS

Primary DI
00884838020429
Brand
PHILIPS
Company
Respironics California, Inc.
Model
1076374
Catalog number
1076374
Device description
Assy Battery Li-Ion,11ah,V60
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNTVentilator, continuous, minimal ventilatory support, facility use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102985000V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc.2011-04-05MNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838020429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838020429008848380204298848380204290884838020429

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Fragile, Dry, Do not put weight over 100 lbs on it. Battery must be recyced or disposed of properly
Special Storage Condition, Specify00Handling Environment Atmospheric Pressure, 600 to 765 mmHg
Special Storage Condition, Specify00Storage Environment Atmospheric Pressure, 600 to 765 mmHg
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500Respironics.Service@Philips.com

Regulatory Flags#

DUNS number
079550876
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838020047Philips RespironicsV6010536162015-10-22
00884838020054Philips RespironicsV6010536172015-10-22
00884838009844PHILIPS105361310536132020-09-22
00884838009851PHILIPS105361410536142020-09-22
00884838009868PHILIPS105361510536152020-09-22
00884838015722PHILIPS10555689898056159912020-09-22
00884838015739PHILIPS10555699898056160012020-09-22
00884838015753PHILIPS10555719898056160212020-09-22
00884838015791PHILIPS10555759898056160612020-09-22
00884838015807PHILIPS10555769898056160712020-09-22
00884838015821PHILIPS10555789898056160812020-09-22
00884838015838PHILIPS10555799898056160912020-09-22
00884838015845PHILIPS10555809898056161012020-09-22
00884838015852PHILIPS10555819898056161112020-09-22
00884838015883PHILIPS10555849898056161412020-09-22
00884838015890PHILIPS10555859898056161512020-09-22
00884838015906PHILIPS10555869898056161612020-09-22
00884838015913PHILIPS10555879898056161712020-09-22
00884838015920PHILIPS10555889898056161812020-09-22
00884838025776PHILIPS107671610767162020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465511Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480866Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
08401934313389ResScanRESMED CORP.MNT2023-02-24
08401934313396ResScanRESMED CORP.MNT2023-02-24
09420012455000Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455062Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455338Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455727Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459695Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460295Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460615Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460639Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460738Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460752Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460776Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460790Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
00606959048720A Series, Sys One, Heater HumRespironics, Inc.MNT2020-10-16
00606959049024DreamMapper Web (DM)Respironics, Inc.MNT2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNT2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNT2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNT2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNT2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNT2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNT2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNT2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959053045DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959054844DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959058552EncoreAnywhereRespironics, Inc.MNT2019-12-29
00606959058569EncoreAnywhereRespironics, Inc.MNT2019-12-29