BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Fisher & Paykel Healthcare

DI: 09420012445261 · Model: OJR215 · FISHER & PAYKEL HEALTHCARE LIMITED

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Fisher & Paykel Healthcare
Primary DI: 09420012445261
Version / Model: OJR215
Catalog Number: OJR215
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
Labeler DUNS: 590153276
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2023-07-06
Public Version: 1
Public Version Date: 2023-07-14
Public Version Status: New
Public Device Record Key: 3673d635-5c18-4c94-aa89-c3ea8d40e5f0

Device Description

PRESSURE RELIEF MANIFOLD NHF

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34142	Pressure relief valve, single-use	A non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09420012445278	GS1	BOX	5	In Commercial Distribution
Primary	09420012445261	GS1

Customer Contacts

Phone: 1800 446 3908
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173770	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius