AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012403117)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900MR761
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900MR761
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012403117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: Adult reusable circuit 1.5 m with watertrap

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
37705	Ventilator breathing circuit, reusable	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913368	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51153967-53e6-495e-9e07-1763df03208e
Public Version Date: December 11, 2019
Public Version Number: 4
DI Record Publish Date: September 08, 2016