PocketPEP Advantage with OxyJET

FDA UDI

Class II (US FDA UDI)

by D R Burton Healthcare, Llc

Identity

Trade Name: PocketPEP Advantage with OxyJET FDA UDI
Generic Name: Incentive spirometer FDA UDI
Device Name: A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen. FDA UDI
Model / Reference: 1 FDA UDI
Description: A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen. FDA UDI

Identifiers

Catalog Number: 538 FDA UDI
Primary DI / UDI-DI: 10851232007728 FDA UDI
510(k) Number: K160636 FDA UDI
FDA Product Code: BWF FDA UDI
GMDN Term: Incentive spirometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Incentive spirometer

PocketPEP Advantage with OxyJET by D R Burton Healthcare, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Incentive spirometer.

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AincA® — Anesthesia Associates, Inc. · Class II
THRESHOLD — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
AirLife — Airlife, Inc. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K160636 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: D R Burton Healthcare, Llc

Sources (1)

FDA UDI f73a2b13-48a3-489f-b7aa-574eb8d61cd1 36 fields · synced Jun 6, 2026