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Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
Curaplex THS VibraPEP, Filter, and Neb Kit FDA UDI
Model / Reference
301-670255-KIT FDA UDI
Description
Curaplex THS VibraPEP, Filter, and Neb Kit FDA UDI

Identifiers

Catalog Number
301-670255-KIT FDA UDI
Primary DI / UDI-DI
00810094575021 FDA UDI
FDA Product Code
CAI FDA UDI
BWF FDA UDI
CAF FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5240 FDA UDI
868.5690 FDA UDI
868.5630 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Positive pressure airway secretion-clearing device

Curaplex by Bound Tree Medical, Llc — 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
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI 2fa85270-3521-41f3-9f28-07c9fc6b98dd 34 fields · synced Jun 8, 2026