FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012402707
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900MR529
Catalog number
900MR529
Device description
Reusable breathing tubing 15mm x 1.3m
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
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012402707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012402707094200124027079420012402707

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

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

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