AccessGUDID - DEVICE: WaterPAP™ Pro Starter Kit (00709078013621)

GUDID

Device Identifier (DI) Information

Brand Name: WaterPAP™ Pro Starter Kit
Version or Model: WP-7805
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078013621
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: WaterPAP™ Pro Starter Kit Product Packaged in a UofU

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?
46823	PEEP valve, single-use	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYE	Attachment, Breathing, Positive End Expiratory Pressure

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99d2e5cc-1deb-453f-a312-a24748b893b7
Public Version Date: May 17, 2024
Public Version Number: 3
DI Record Publish Date: October 08, 2021