AccessGUDID - DEVICE: Vapotherm (00841737104872)

GUDID

Device Identifier (DI) Information

Brand Name: Vapotherm
Version or Model: PF-DPC-HIGH-AJ5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VAPOTHERM, INC.

Primary DI Number: 00841737104872
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040429050 *Terms of Use

Device Description: Precision Flow Disposable Patient Circuit, High AJ5 (Made in Mexico Liberty DPC) (Customer Facing)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
57828	Professional high-flow respiratory unit, humidifying, manual	An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a healthcare provider as part of noninvasive ventilation (NIV), in a peri-anaesthesia environment, or for a patient experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD)]. It typically consists of a gas flow generator, a heating element, and humidification chamber.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 03b3a321-a39f-430f-b856-20c39c9b8538
Public Version Date: April 21, 2025
Public Version Number: 4
DI Record Publish Date: August 24, 2021