Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Basic endotracheal tube, single-use FDA UDI
Device Name: Curaplex Endotracheal Tube with Stylette, 9.5mm, Cuffed 10ea/bx 10bx/cs FDA UDI
Model / Reference: 38021 FDA UDI
Description: Curaplex Endotracheal Tube with Stylette, 9.5mm, Cuffed 10ea/bx 10bx/cs FDA UDI

Identifiers

Primary DI / UDI-DI: 00815277027175 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Basic endotracheal tube, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 9.5 Millimeter FDA UDI

Category: Basic endotracheal tube, single-use

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

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Also classified as Basic endotracheal tube, single-use.

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Endotracheal Tubes — Dynarex Corp. · Class II
ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI 2ab410db-56f8-46f7-abf3-244e9e0b1236 34 fields · synced May 30, 2026