PocketPEP

GUDID 10851232007568

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 ID10851232007568
NIH Device Record Key46e0de36-4eb6-4ef3-aad4-9de95b362c68
Commercial Distribution StatusIn Commercial Distribution
Brand NamePocketPEP
Version Model Number1
Company DUNS080384219
Company NameD R BURTON HEALTHCARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com
Phone2522287038
Emailinquiries@drburtonhpi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110851232007568 [Package]
Contains: 10851232007575
Package: Case [10 Units]
In Commercial Distribution
GS110851232007575 [Primary]
GS120851232007572 [Package]
Contains: 10851232007575
Package: CASE [2 Units]
In Commercial Distribution
GS190851232007571 [Package]
Contains: 10851232007575
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-11-17
Device Publish Date2018-01-02

Devices Manufactured by D R BURTON HEALTHCARE, LLC

10851232007018 - vPEP2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007025 - vPEP-HC2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007520 - iPEP2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007568 - PocketPEP2023-11-17This 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.
10851232007568 - PocketPEP2023-11-17 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
10851232007551 - PocketPEP Advantage2021-07-09 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
30851232007685 - PocketPEP with OxyJET2020-04-20 A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxyg
30851232007722 - PocketPEP Advantage with OxyJET2020-04-20 A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compre
30851232007111 - J-Wand Advantage2020-03-27 Single-use, rigid intubating stylet.

Trademark Results [PocketPEP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POCKETPEP
POCKETPEP
86822792 5277110 Live/Registered
D R Burton Healthcare, LLC
2015-11-17

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