FDA.reportPublic FDA data

Fisher and Paykel Healthcare

Primary DI
09420012432094
Brand
Fisher and Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
OPT546
Catalog number
OPT546
Device description
Optiflow Nasal Cannula MR850 Large
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012422804PackageGS120In Commercial Distribution
09420012432094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012422804094200124228049420012422804
09420012432094094200124320949420012432094

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basic"A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as ""nasal prongs"". This is a single-use device."

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
590153276
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012432162Fisher & Paykel HealthcareRT241RT2412022-08-02
09420012414557Fisher & Paykel Healthcare900MR441900MR4412022-08-02
09420012477477F&P OptiNIVONIV117AONIV117A2025-12-06
09420012477484F&P OptiNIVONIV117BONIV117B2025-12-06
09420012477491F&P OptiNIVONIV117CONIV117C2025-12-06
09420012480446F&P OptiNIVONIV117A-FONIV117A-F2025-12-06
09420012480460F&P OptiNIVONIV117B-FONIV117B-F2025-12-06
09420012480484F&P OptiNIVONIV117C-FONIV117C-F2025-12-06
09420012424815Fisher & Paykel HealthcareRT013ERT013E2022-08-02
09420012432155Fisher & Paykel HealthcareRT013RT0132022-08-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950293Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874950750Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951016Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951344Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951351Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951368Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951375Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951399Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951405Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951412Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952075Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952082Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954826Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954833Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954840Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954857Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954864Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954871Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954888Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954895Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
00607411919077Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919091Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919121Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26