FDA.report

Fisher & Paykel Healthcare

Primary DI
09420012419040
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
RD050-01
Catalog number
RD050-01
Device description
Neopuff Central Mounting Bracket
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FOXStand, Infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09420012419040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09420012419040094200124190409420012419040

GMDN Terms

TermDefinition
Portable active medical device mountA device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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

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