Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Breathing circuit condensate trap, reusable FDA UDI
Device Name: *Custom* Berry Blood Draw Kit FDA UDI
Model / Reference: 8600-01440 FDA UDI
Description: *Custom* Berry Blood Draw Kit FDA UDI

Identifiers

Catalog Number: 8600-01440 FDA UDI
Primary DI / UDI-DI: 00812277036176 FDA UDI
FDA Product Code: GJE FDA UDI
CBT FDA UDI
GMDN Term: Breathing circuit condensate trap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
868.1100 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: Breathing circuit condensate trap, reusable

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

Similar devices

Also classified as Breathing circuit condensate trap, reusable.

Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
Water Trap — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
WaterLock2 — Drägerwerk AG & Co. KGaA · Class I
Convenience Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
WT 250 Water Trap — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
Expression MR KIT, DISPOSABLE WATER TRAP, 3160 — Philips DS North America LLC · Class II
HG 100 Humidifier Guard — INSTRUMENTATION INDUSTRIES, INCORPORATED · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI 517530f3-45e6-45d1-93ba-6799f72a4ab9 34 fields · synced Jun 1, 2026