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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
Mechanical external stethoscope FDA UDI
Device Name
Curaplex EMT Student Kit FDA UDI
Model / Reference
51089 FDA UDI
Description
Curaplex EMT Student Kit FDA UDI

Identifiers

Catalog Number
51089 FDA UDI
Primary DI / UDI-DI
00815277021128 FDA UDI
FDA Product Code
CBP FDA UDI
DXQ FDA UDI
GMDN Term
Mechanical external stethoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5870 FDA UDI
870.1120 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: Aneroid manual sphygmomanometerMechanical external stethoscopeCardiopulmonary resuscitation mask, single-use

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

Similar devices

Also classified as Cardiopulmonary resuscitation mask, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 13dc3535-80b8-4584-95a8-62e7bdf033aa 34 fields · synced Jun 8, 2026