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Curaplex

FDA UDI

Class II (US FDA UDI)

by Tri-Anim Health Services, Inc.

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
OSCILLATORY PEP THERAPY SYSTEM,VIBRAPEP,OPEP,INTRODUCER,T-PIECE,LATEX FREE,DEHP FREE FDA UDI
Model / Reference
301-44F50-100 FDA UDI
Description
OSCILLATORY PEP THERAPY SYSTEM,VIBRAPEP,OPEP,INTRODUCER,T-PIECE,LATEX FREE,DEHP FREE FDA UDI

Identifiers

Primary DI / UDI-DI
00812574022032 FDA UDI
510(k) Number
K153441 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Positive pressure airway secretion-clearing device

Curaplex by Tri-Anim Health Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Cleared under the same submission

K153441 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tri-Anim Health Services, Inc.

Sources (1)

  • FDA UDI 299691dc-919a-499c-9ad8-471f0a9de5ee 34 fields · synced May 30, 2026