FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012425355
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900ICON205
Catalog number
900ICON205
Device description
ICON Oxygen Elbow
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012425355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012425355094200124253559420012425355

GMDN Terms#

Term, Definition table
TermDefinition
Tube/mask breathing circuit connector, reusableA device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It may be made of plastic and/or metal and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 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
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
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425041Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448521Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448736Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
04719893347272WellellWellell Inc.BZD2026-03-17
09420012461629F&P ViteraFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-01-27
09420012472212NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472229NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472236NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472243NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472366NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472373NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472380NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472397NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
08056814676223DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676247DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676254DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20