Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Cardiopulmonary resuscitation kit, reusable FDA UDI
Device Name: Curaplex Nasopharyngeal Airway Set, Latex Free, includes Sizes 20-24-26-28-32 and 34 Fr FDA UDI
Model / Reference: 028055 FDA UDI
Description: Curaplex Nasopharyngeal Airway Set, Latex Free, includes Sizes 20-24-26-28-32 and 34 Fr FDA UDI

Identifiers

Catalog Number: 028055 FDA UDI
Primary DI / UDI-DI: 00815277028288 FDA UDI
FDA Product Code: BTQ FDA UDI
GMDN Term: Cardiopulmonary resuscitation kit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary resuscitation kit, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI a9d8199e-6cd3-4d3d-97ee-8ae755516c74 34 fields · synced Jun 1, 2026