FDA.reportPublic FDA data

Li Ion Battery, Ventilation, Japan

Primary DI
00606959033344
Brand
Li Ion Battery, Ventilation, Japan
Company
Respironics, Inc.
Model
00
Catalog number
1126945
Device description
Li Ion Battery, Ventilation, rechargable battery pack, Japan
Published
2019-06-05
Public version status
New
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
MNTVentilator, continuous, minimal ventilatory support, facility use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959033344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959033344006069590333446069590333440606959033344

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500RESPIRONICS.SERVICE@PHILIPS.COM

Regulatory Flags#

DUNS number
080728314
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465528Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480873Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
07321820070145Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820072026Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820073801Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820070794Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-19
07321822290008Vivo 3Breas Medical ABMNT2025-05-19
09420012466679Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2024-09-11
07325710015117Servo-air LiteMaquet Critical Care ABMNT2023-09-21
10843685100057Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
10843685100064Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
20843685100078Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
00843685100135Nihon KohdenNIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
10843685100170Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
09420012455710Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012454973Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455345Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455734Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459701Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460301Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460622Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460646Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460745Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460769Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460783Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460806Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
00843685100043Nihon KohdenNIHON KOHDEN ORANGEMED, INC.MNT2022-07-18
00606959054165BiPAPRespironics, Inc.MNT2021-05-28
00606959059443BiPAPRespironics, Inc.MNT2021-03-19
00606959059450BiPAP A40 EFL, ARRespironics, Inc.MNT2021-03-19