iPEP

GUDID 10851232007520

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.

D R BURTON HEALTHCARE, LLC

Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer

• Primary Device ID: 10851232007520
• NIH Device Record Key: 1b630033-9247-4e07-9595-99460a57a652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iPEP
• Version Model Number: 1
• Company DUNS: 080384219
• Company Name: D R BURTON HEALTHCARE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com
• Phone: 2522287038
• Email: inquiries@drburtonhpi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851232007520 [Package]; Contains: 10851232007537; Package: Case [10 Units]; In Commercial Distribution
GS1	10851232007537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160636

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2018-01-02

Devices Manufactured by D R BURTON HEALTHCARE, LLC

• 10851232007018 - vPEP: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007025 - vPEP-HC: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007520 - iPEP: 2023-11-17This 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.
• 10851232007520 - iPEP: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007568 - PocketPEP: 2023-11-17 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
• 10851232007551 - PocketPEP Advantage: 2021-07-09 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
• 30851232007685 - PocketPEP with OxyJET: 2020-04-20 A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxyg
• 30851232007722 - PocketPEP Advantage with OxyJET: 2020-04-20 A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compre
• 30851232007111 - J-Wand Advantage: 2020-03-27 Single-use, rigid intubating stylet.