FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012402141
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900MR139
Catalog number
900MR139
Device description
Autoclavable watertrap
Published
2022-08-02
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
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
09420012402141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012402141094200124021419420012402141

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, reusableA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator 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 the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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44710810119499N/AGALEMED CORPORATIONBYH2026-03-04
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44710810119543N/AGALEMED CORPORATIONBYH2026-03-04
44710810119550N/AGALEMED CORPORATIONBYH2026-03-04
44710810119567N/AGALEMED CORPORATIONBYH2026-03-04
44710810119574N/AGALEMED CORPORATIONBYH2026-03-04
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20197344011015HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
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30889483571914AirLife™Sunmed Group Holdings, LLCBYH2025-03-28
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30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
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10889483585757AirLife™AIRLIFEBYH2025-02-12
30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12