FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012432377
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
RT032
Catalog number
RT032
Device description
Respiratory Care System- Watertrap
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
BYHDrain, Tee (Water Trap)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012415264PackageGS120In Commercial Distribution
09420012432377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012415264094200124152649420012415264
09420012432377094200124323779420012432377

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, single-useA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09420012429810FISHER & PAYKEL HEALTHCARE RT008RT0082015-09-25
09420012416810Fisher & Paykel HealthcareHC550JHUHC550JHU2016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04710810084157N/AGALEMED CORPORATIONBYH2026-03-04
04710810119491N/AGALEMED CORPORATIONBYH2026-03-04
04710810119507N/AGALEMED CORPORATIONBYH2026-03-04
04710810119545N/AGALEMED CORPORATIONBYH2026-03-04
04710810119552N/AGALEMED CORPORATIONBYH2026-03-04
04710810119569N/AGALEMED CORPORATIONBYH2026-03-04
04710810119576N/AGALEMED CORPORATIONBYH2026-03-04
24710810084151N/AGALEMED CORPORATIONBYH2026-03-04
44710810119499N/AGALEMED CORPORATIONBYH2026-03-04
44710810119505N/AGALEMED CORPORATIONBYH2026-03-04
44710810119543N/AGALEMED CORPORATIONBYH2026-03-04
44710810119550N/AGALEMED CORPORATIONBYH2026-03-04
44710810119567N/AGALEMED CORPORATIONBYH2026-03-04
44710810119574N/AGALEMED CORPORATIONBYH2026-03-04
10197344011018HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
20197344011015HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
10889483571910AirLife™AIRLIFEBYH2025-03-28
30889483571914AirLife™Sunmed Group Holdings, LLCBYH2025-03-28
10889483570937AirLife™AIRLIFEBYH2025-03-18
10889483570951AirLife™AIRLIFEBYH2025-03-18
30889483570931AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
30889483570955AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
10889483570777AirLife™AIRLIFEBYH2025-02-20
10889483570784AirLife™AIRLIFEBYH2025-02-20
10889483570944AirLife™AIRLIFEBYH2025-02-20
30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570788AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570948AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
10889483585757AirLife™AIRLIFEBYH2025-02-12
30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12