Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Fixed medical gas cylinder regulator FDA UDI
Device Name: Curaplex Oxygen Regulator, All-Brass, 2 DISS, 1 Barb, CGA870 FDA UDI
Model / Reference: EMSREG8725-B2D-BTM FDA UDI
Description: Curaplex Oxygen Regulator, All-Brass, 2 DISS, 1 Barb, CGA870 FDA UDI

Identifiers

Catalog Number: 14288 FDA UDI
Primary DI / UDI-DI: 00810071635953 FDA UDI
FDA Product Code: CAN FDA UDI
GMDN Term: Fixed medical gas cylinder regulator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Fixed medical gas cylinder regulator

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 a9fa400c-c484-4933-9f28-5af96b877f81 34 fields · synced May 30, 2026