FDA.reportPublic FDA data

Fisher and Paykel Healthcare

Primary DI
09420012407160
Brand
Fisher and Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
MR850ADU
Catalog number
MR850ADU
Device description
Humidifier MR850 230V DA DAN
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012407160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012407160094200124071609420012407160

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
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
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
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

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