AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012423115)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900ICON202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900ICON202
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012423115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: F&P InfoUSB

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?
46563	Digital storage media	A portable electronic device designed to record and store data from an electronic source (e.g., a computer), storing the information in a digital format so that the data can be copied or retrieved (read or downloaded) using computer technology. It may be one of a variety of formats (e.g., recordable DVD, recordable CD, USB flash drive, MO disc, UDO disc, floppy disc).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	Ventilator, Non-Continuous (Respirator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edbc307e-2faa-498d-8c38-a785f121fe65
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: September 08, 2016