Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Oxygen administration tubing FDA UDI
Device Name: Curaplex Pediatric BVM with Filterline Kit FDA UDI
Model / Reference: 670251-KIT FDA UDI
Description: Curaplex Pediatric BVM with Filterline Kit FDA UDI

Identifiers

Catalog Number: 670251-KIT FDA UDI
Primary DI / UDI-DI: 00810094575953 FDA UDI
FDA Product Code: BTL FDA UDI
BTM FDA UDI
GMDN Term: Oxygen administration tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 FDA UDI
868.5915 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Oxygen administration tubing Pulmonary resuscitator, manual, reusable

Curaplex by Bound Tree Medical, Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI dfafd7b2-f874-4ac7-b325-0055f788d40a 34 fields · synced Jun 1, 2026