FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012454973
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
RT047XS
Catalog number
RT047XS
Device description
Nivairo RT047 Vented Hospital Full Face Mask , Anti-Asphyxiation Valve Version- Extra Small
Published
2022-08-02
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012454973PackageGS110In Commercial Distribution
09420012455062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012454973094200124549739420012454973
09420012455062094200124550629420012455062

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800 446 3908Customer.CareUSA@fphcare.com

Regulatory Flags#

DUNS number
590153276
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
09420012429803FISHER & PAYKEL HEALTHCARERT0010T292015-09-25
09420012405913Fisher & Paykel Healthcare900MR011900MR0112026-03-23
09420012429810FISHER & PAYKEL HEALTHCARE RT0080T292015-09-25
09420012429940FISHER & PAYKEL HEALTHCARE900RD014-10900RD014-102015-09-25
09420012429957FISHER & PAYKEL HEALTHCARE900RD015-10900RD015-102015-09-25
09420012429964FISHER & PAYKEL HEALTHCARE900RD016-10900RD016-102015-09-25
09420012416582FISHER & PAYKEL HEALTHCARE900RD110900RD1102015-09-25
09420012430021FISHER & PAYKEL HEALTHCARERD1340-10RD1340-102015-09-25
09420012430038FISHER & PAYKEL HEALTHCARERD1341-102015-09-25
09420012430045FISHER & PAYKEL HEALTHCARERD1350-10RD1350-102015-09-25
09420012430052FISHER & PAYKEL HEALTHCARERD1351-10RD1351-102015-09-25
09420012430076FISHER & PAYKEL HEALTHCARERD1360-10RD1360-102015-09-25
09420012430083FISHER & PAYKEL HEALTHCARERD1361-10RD1361-102015-09-25
09420012430090FISHER & PAYKEL HEALTHCARERD1370-10RD1370-102015-09-25
09420012430106FISHER & PAYKEL HEALTHCARERD1371-10RD1371-102015-09-25
09420012430113FISHER & PAYKEL HEALTHCARERD803-10RD803-102015-09-25
09420012430120FISHER & PAYKEL HEALTHCARE RD804-100W902015-09-25
09420012430137FISHER & PAYKEL HEALTHCARE RD805-10RD805-102015-09-25
09420012430144FISHER & PAYKEL HEALTHCARE RD806-10RD806-102015-09-25
09420012430151FISHER & PAYKEL HEALTHCARE RD807-10RD807-102015-09-25

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
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
00606959059474BiPAPRespironics, Inc.MNT2021-03-19