FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012414823
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900IW205
Catalog number
900IW205
Device description
X-Ray Tray Module
Published
2016-09-08
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
FMTWarmer, Infant Radiant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971695000SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMERFisher & Paykel Electronics , Ltd.1997-07-28FMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012414823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012414823094200124148239420012414823

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
590153276
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012436047Fisher & Paykel HealthcareWJR210WJR2102026-04-14
09420012436061Fisher & Paykel HealthcareWJR212WJR2122026-04-14
09420012474643F&P 850850A61J850A61J2026-04-13
09420012405890Fisher & Paykel Healthcare900HC031900HC0312026-04-08
09420012409690Fisher & Paykel Healthcare900RD302900RD3022026-04-08
09420012416728Fisher & Paykel Healthcare900HC033900HC0332026-04-08
09420012425911Fisher & Paykel HealthcareOPT31POPT31P2026-04-08
09420012425928Fisher & Paykel HealthcareOPT31NOPT31N2026-04-08
09420012430410Fisher & Paykel HealthcareRT205RT2052026-04-08
09420012449818Fisher & Paykel HealthcareRT331RT3312026-04-08
09420012429810FISHER & PAYKEL HEALTHCARE RT008RT0082015-09-25
09420012416810Fisher & Paykel HealthcareHC550JHUHC550JHU2016-09-08
09420012429933FISHER & PAYKEL HEALTHCARE900RD010900RD0102015-09-25
09420012445445Fisher & Paykel HealthcareBC2425-20BC2425-202023-07-06
09420012407221MR850MR850AFUMR850AFU2016-09-08
09420012416797Fisher and Paykel HealthcareHC550AFUHC550AFU2022-08-02
09420012430700Fisher & Paykel HealthcareRT245RT2452022-08-02
09420012433145Fisher & Paykel HealthcareNC020-20NC020-202016-09-08
09420012433152Fisher & Paykel HealthcareNC021-20NC021-202016-09-08
09420012433930Fisher & Paykel Healthcare900MR161L900MR161L2022-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMT2026-03-23
10889483587881AirLife™AirLife Finland OyFMT2025-03-26
10889483587904AirLife™AirLife Finland OyFMT2025-03-26
20889483587888AirLife™AirLife Finland OyFMT2025-03-26
20889483587901AirLife™AirLife Finland OyFMT2025-03-26
10889483587959AirLife™AirLife Finland OyFMT2025-03-26
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
04049098099042Babyroo TN300 Infant Radiant WarmerDRAEGER MEDICAL SYSTEMS, INC.FMT2023-06-08
00749756379205DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
50749756379200DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMT2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMT2021-11-10
00749756772358DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
30749756772359DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
00749756927550DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927567DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927574DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756983983DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756995566DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927555DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927562DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927579DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756983988DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756995561DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756372305DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
50749756372300DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
10190752181236Airlife™AirLife Finland OyFMT2021-03-09
10190752181199Airlife™AirLife Finland OyFMT2021-03-05
20190752181196Airlife™VYAIRE MEDICAL, INC.FMT2021-03-05