PocketPEP with OxyJET 537

GUDID 30851232007685

A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.

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 Incentive spirometer
Primary Device ID30851232007685
NIH Device Record Key478879ac-7d40-4bc3-9900-a2fb70849ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePocketPEP with OxyJET
Version Model Number1
Catalog Number537
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 Kittrue
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
Phone2522287038
Emailinquiries@drburtonhpi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110851232007681 [Primary]
GS130851232007685 [Package]
Contains: 10851232007681
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

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 - PocketPEP2023-11-17 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 OxyJET2020-04-20A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.
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.

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