Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Pneumothorax catheter insertion set FDA UDI
Device Name: Curaplex Thoracentesis Kit FDA UDI
Model / Reference: 18311 FDA UDI
Description: Curaplex Thoracentesis Kit FDA UDI

Identifiers

Catalog Number: 18311 FDA UDI
Primary DI / UDI-DI: 00815277020251 FDA UDI
FDA Product Code: KGZ FDA UDI
KDQ FDA UDI
FMF FDA UDI
GMDN Term: Pneumothorax catheter insertion set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
880.6740 FDA UDI
880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Pneumothorax catheter insertion set

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 c0a789cd-1c8f-4358-a849-1782edd90c48 34 fields · synced Jun 8, 2026