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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
Tracheostomy tube cannula, single-use FDA UDI
Device Name
CANNULA, ADULT SOFT,UP TO 15LPM, CURVED PRONGS-14' KINK RESIS TUBE W/UNIVERSAL CONNECTOR FDA UDI
Model / Reference
301-PSCU11415 FDA UDI
Description
CANNULA, ADULT SOFT,UP TO 15LPM, CURVED PRONGS-14' KINK RESIS TUBE W/UNIVERSAL CONNECTOR FDA UDI

Identifiers

Catalog Number
301-PSCU11415 FDA UDI
Primary DI / UDI-DI
00812277037180 FDA UDI
FDA Product Code
CAT FDA UDI
GMDN Term
Tracheostomy tube cannula, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5340 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

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: Tracheostomy tube cannula, single-use

Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube cannula, single-use.

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 4d6ee9f3-07f2-40c6-a747-4bb95c739fe8 34 fields · synced May 30, 2026