FDA.report

Fisher & Paykel Healthcare

Primary DI
09420012437341
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
OPT980E
Catalog number
OPT980E
Device description
Optiflow Mask Interface Adapter (Single)
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

Related Records

Contact Domains

Product Codes

CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09420012437341PackageGS120In Commercial Distribution
09420012436948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09420012437341094200124373419420012437341
09420012436948094200124369489420012436948

GMDN Terms

TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile 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 is typically made of plastic materials 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 single-use device.

Sterilization Methods

Method

Contacts

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
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 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 DIBrandCompanyProduct codePublished
64897132250476TECMEVINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-17
64897132250315inspired™VINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-05
30889483631472AirLifeSUNMED, LLCBTT2026-02-27
09420012481757F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481801F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481825F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344007165HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-03
20197344005991HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
20197344009722HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
10889483648162AirLife™AIRLIFEBTT2026-01-14
20197344009821HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009852HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009869HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009876HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029706HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029713HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029720HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009586HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344009845HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011022HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011053HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
54026704734097HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
54026704734103HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
07321820069774Vivo 1/2, Vivo 3Breas Medical ABBTT2025-05-19
10889483631416AirLife™AIRLIFEBTT2025-04-21
10889483631423AirLife™AIRLIFEBTT2025-04-21
10889483631430AirLife™AIRLIFEBTT2025-04-21
10889483631447AirLife™AIRLIFEBTT2025-04-21
10889483631454AirLife™AIRLIFEBTT2025-04-21
10889483631461AirLife™AIRLIFEBTT2025-04-21