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Pep-S

FDA UDI

Class II (US FDA UDI)

by Pari Respiratory Equipment, Inc.

Identity

Trade Name
PEP-S FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
PEP-S Positive Expiratory Pressure System FDA UDI
Model / Reference
018F63 FDA UDI
Description
PEP-S Positive Expiratory Pressure System FDA UDI

Identifiers

Primary DI / UDI-DI
00744229180128 FDA UDI
510(k) Number
K090829 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

Pep-S 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 3f90d82a-3af2-4f0e-9316-31c4ddf4691e 34 fields · synced May 31, 2026