AccessGUDID - DEVICE: vPEP-HC (10851232007025)

GUDID

Device Identifier (DI) Information

Brand Name: vPEP-HC
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: D R BURTON HEALTHCARE, LLC

Primary DI Number: 10851232007025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080384219 *Terms of Use

Device Description: This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.

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":	Yes
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?
31266	Incentive spirometer	A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWF	Spirometer, Therapeutic (Incentive)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160636	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd06a7e8-7cf3-4ce6-a7dc-a439eec4196f
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: October 24, 2018