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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,NASAL,OXY,CURAPLEX,ADL,COMFORT SOFT PLUS,7' TUBING 50/CA FDA UDI
Model / Reference
301-PSC107 FDA UDI
Description
CANNULA,NASAL,OXY,CURAPLEX,ADL,COMFORT SOFT PLUS,7' TUBING 50/CA FDA UDI

Identifiers

Catalog Number
301-PSC107 FDA UDI
Primary DI / UDI-DI
00812277037265 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 69a3248d-2983-4c7a-8e64-983630d6c6fb 34 fields · synced May 31, 2026