Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER - EXTENDED FDA UDI
Model / Reference: 5107ET-E FDA UDI
Description: ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER - EXTENDED FDA UDI

Identifiers

Catalog Number: 301-5107ET-E FDA UDI
Primary DI / UDI-DI: 00810071631870 FDA UDI
510(k) Number: K063813 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 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

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 7 Feet FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

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

Similar devices

Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.

CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
Dispo-Med CO2 Sampling Line, MLL, W/Filter — DISPO-MED (MALAYSIA) SDN. BHD. · Class II
Gas Sampling Lines — SALTER LABS · Class II
Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
Omnistream — ORIDION MEDICAL 1987 LTD. · Class II
Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
AirLife™ — Airlife, Inc. · Class II

Cleared under the same submission

K063813 also covers:

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 1164e0c3-979c-4f80-a184-47a481a33f82 37 fields · synced Jun 1, 2026