AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012406057)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900MR087
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900MR087
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012406057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: Bracket (for use with pole)

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?
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: cc031dfe-1753-4f80-8c6a-708ba3ab5fa3
Public Version Date: August 10, 2022
Public Version Number: 1
DI Record Publish Date: August 02, 2022