Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: CPAP/BPAP nasal mask, single-use FDA UDI
Device Name: CPAP/Capno Kit, O2MAX Guard Bitrac ED Mask, FIXED FLOW, MED, 3-SET Valve, CO2 Sampling Line, Neb FDA UDI
Model / Reference: 670214-KIT FDA UDI
Description: CPAP/Capno Kit, O2MAX Guard Bitrac ED Mask, FIXED FLOW, MED, 3-SET Valve, CO2 Sampling Line, Neb FDA UDI

Identifiers

Catalog Number: 670214-KIT FDA UDI
Primary DI / UDI-DI: 00812277037104 FDA UDI
FDA Product Code: BYE FDA UDI
GMDN Term: CPAP/BPAP nasal mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5965 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: CPAP/BPAP unit ambient air filter, single-use CPAP/BPAP nasal mask, 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 CPAP/BPAP nasal mask, single-use.

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BiTrac HC — Pulmodyne Inc. · Class II
FitStar Hospital Nasal Non Vented Mask, s/m — Sleepnet Corporation · Class II
Whisper Soft — Engineered Medical Systems, LLC · Class II
BiTrac — Pulmodyne Inc. · 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 77a65526-3087-460e-9c4d-e841a81d9f01 34 fields · synced May 29, 2026