Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: TRANSPORT CIRCUIT,W/19MM ADJ PEEP (5-20CM H2O)W/30MM ADAP & 9' EXPANDALE CORR TUBING FDA UDI
Model / Reference: 1004SP-A FDA UDI
Description: TRANSPORT CIRCUIT,W/19MM ADJ PEEP (5-20CM H2O)W/30MM ADAP & 9' EXPANDALE CORR TUBING FDA UDI

Identifiers

Catalog Number: 301-1004SP-A FDA UDI
Primary DI / UDI-DI: 00810071636424 FDA UDI
FDA Product Code: CAI FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5240 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

FDA UDI

Combination Product

Yes

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Anaesthesia breathing circuit, single-use

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 1ce762b4-162d-4ac6-999c-24bb07d32997 34 fields · synced May 30, 2026