AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012418722)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900IW003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900IW003
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012418722
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: Adaptor for single use temperature sensors

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?
17433	Infant warmer	A mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMT	Warmer, Infant Radiant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971695	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 -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bed89c4c-0cda-41d0-828f-2f07ef96935a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2016