AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012480149)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: AA520J
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AA520J
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012480149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: F&P Optiflow Flow Diverter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37025	Pressure relief valve, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBP	Valve, Non-Rebreathing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234053	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfb7a1b5-01fe-47d4-8793-98b28750f89f
Public Version Date: September 19, 2024
Public Version Number: 1
DI Record Publish Date: September 11, 2024