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

• 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.