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Curaplex

FDA UDI

Class I (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
Valved Tee Adapter, VibraPEP, 22mm OD x 18 mm ID, 22 mm ID side port FDA UDI
Model / Reference
301-12218 FDA UDI
Description
Valved Tee Adapter, VibraPEP, 22mm OD x 18 mm ID, 22 mm ID side port FDA UDI

Identifiers

Catalog Number
301-12218 FDA UDI
Primary DI / UDI-DI
00818834028134 FDA UDI
FDA Product Code
BZO FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5975 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

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 I — 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
Tri-Anim Health Services, Inc.

Sources (1)

  • FDA UDI cadc3d7e-e473-4929-87b0-87a64fa363c5 34 fields · synced May 31, 2026