AccessGUDID - DEVICE: F&P OptiPAP Junior (09420012479129)

GUDID

Device Identifier (DI) Information

Brand Name: F&P OptiPAP Junior
Version or Model: OPTIPAPC2330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPTIPAPC2330
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012479129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: OptiPAP Junior Chinstrap 23-30cm

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:	Yes
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?
65873	CPAP/BPAP chin strap, single-use	A non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal/infant to adult patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

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
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 17-24CM

Device Record Status

Public Device Record Key: b2dbf4a2-29b3-49d8-b1e6-f53a24967603
Public Version Date: February 02, 2026
Public Version Number: 1
DI Record Publish Date: January 23, 2026