FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012447036
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
AA503
Catalog number
AA503
Device description
Optiflow Thrive Vertical Clamp Mounting Humidifier Pole
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012447036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012447036094200124470369420012447036

GMDN Terms#

Term, Definition table
TermDefinition
Medical device service rail clampA clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed.

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
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
00810050863377ServiPlexLIFEPORT, LLCFOX2026-02-19
00810050863384ServiPlexLIFEPORT, LLCFOX2026-02-19
00761887005372PhotonicarePRYOR PRODUCTSFOX2026-02-16
00761887005389PhotonicarePRYOR PRODUCTSFOX2026-02-16
04061162071280CIM med GmbHCIM med GmbHFOX2026-02-01
04061162071310CIM med GmbHCIM med GmbHFOX2026-02-01
00810050863360Transition DeckLIFEPORT, LLCFOX2026-01-27
04061162100096CIM med GmbHCIM med GmbHFOX2026-01-14
00841027103233Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-01-08
00761887005358BaxterPRYOR PRODUCTSFOX2026-01-05
00761887005341PryorPRYOR PRODUCTSFOX2025-12-31
00041298995166HealthSmartD-M-S HOLDINGS, INC.FOX2025-12-29
06973456941064CORITONCORITON Instrument Co.,LtdFOX2025-12-29
06973456941071CORITONCORITON Instrument Co.,LtdFOX2025-12-29
04061162087212CIM med GmbHCIM med GmbHFOX2025-12-14
04260217220332AMTRION Infusion S-0725-F-2-SAmtrion GmbHFOX2025-12-10
00841027103226Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2025-11-29
06973456941033CORITONCORITON Instrument Co.,LtdFOX2025-11-27
00841027100324Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102472Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102489Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102496Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26