Curaplex®

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex® FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Device Name: Curaplex Select Adult BVM, Manometer, PEEP, Bacterial Filter, with EtCO2 Sampling Line 10/CS FDA UDI
Model / Reference: 2442-BVMPAD-ET FDA UDI
Description: Curaplex Select Adult BVM, Manometer, PEEP, Bacterial Filter, with EtCO2 Sampling Line 10/CS FDA UDI

Identifiers

Catalog Number: 2442-BVMPAD-ET FDA UDI
Primary DI / UDI-DI: 00810094577537 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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

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

MRI Safety

MR Conditional FDA UDI

Category: Pulmonary resuscitator, manual, 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 Pulmonary resuscitator, manual, single-use.

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SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

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 373f0134-37bc-4af2-8e45-bc940a94a997 34 fields · synced Jun 1, 2026