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Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
In-line CPAP set, non-nebulizing FDA UDI
Device Name
CPAP/Capnography Kit, O2MAX Bitrac ED Mask, Adult LG, 3-SET Valve, DISS Connect, CO2 Sampling Line FDA UDI
Model / Reference
677555 FDA UDI
Description
CPAP/Capnography Kit, O2MAX Bitrac ED Mask, Adult LG, 3-SET Valve, DISS Connect, CO2 Sampling Line FDA UDI

Identifiers

Catalog Number
677555 FDA UDI
Primary DI / UDI-DI
00815277021845 FDA UDI
FDA Product Code
BYE FDA UDI
CCK FDA UDI
GMDN Term
In-line CPAP set, non-nebulizing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5965 FDA UDI
868.1400 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: In-line CPAP set, non-nebulizing

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

Similar devices

Also classified as In-line CPAP set, non-nebulizing.

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 4db9e211-df0b-4146-a390-8c3bd5ee28f5 34 fields · synced May 30, 2026