AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012420732)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900PT600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900PT600
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012420732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: Disinfection Kit

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?
58881	Dry-heat humidifier disinfection tube	A non-sterile, electrically-powered device intended for total elimination and/or inactivation of microorganisms from non-heat sensitive component(s) of humidifiers designed for dry-heat, high-level disinfection to comply with established infection control practices for respiratory devices used on multiple patients. It consists of a flexible tube that connects between the breathing tube components of the humidifier electrical control unit to create a circuit through which forced air is circulated and heated to the appropriate temperature by its integral electrical heating element. The process is controlled by the humidifier electrical control unit. 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 [?]
K131895	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: f8cb0404-7a5a-4af7-8393-7f425add0e7a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2016