Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: *Custom* Curaplex Children's Hospital Kit Green Pouch FDA UDI
Model / Reference: 8600-01496 FDA UDI
Description: *Custom* Curaplex Children's Hospital Kit Green Pouch FDA UDI

Identifiers

Catalog Number: 8600-01496 FDA UDI
Primary DI / UDI-DI: 00810071633195 FDA UDI
FDA Product Code: LNZ FDA UDI
PHS FDA UDI
BSY FDA UDI
GMDN Term: Airway suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 FDA UDI
868.5110 FDA UDI
868.6810 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

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: Rigid intubation laryngoscope, reusable Airway suction catheter

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

Similar devices

Also classified as Airway suction catheter.

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Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Little Sucker Standard TP — Neotech Products LLC · Class II
Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I

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 b6c82088-2681-4b6a-94a1-1ce0fe9ed50d 34 fields · synced May 30, 2026