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O-Pep

FDA UDI

Class II (US FDA UDI)

by Pari Respiratory Equipment, Inc.

Identity

Trade Name
O-PEP FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
PARI O-PEP System FDA UDI
Model / Reference
018F65 FDA UDI
Description
PARI O-PEP System FDA UDI

Identifiers

Primary DI / UDI-DI
00744229180142 FDA UDI
510(k) Number
K150044 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Positive pressure airway secretion-clearing device

O-Pep by Pari Respiratory Equipment, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pari Respiratory Equipment, Inc.

Sources (1)

  • FDA UDI 3341bcd8-bc70-4204-b7ba-a48ccbbd0979 34 fields · synced Jun 1, 2026