Standard Breathing Circuit with Trach

FDA UDI

Class I (US FDA UDI)

by Meditera Tibbi Malzeme Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name: Standard Breathing Circuit with Trach FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Device Name: An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. FDA UDI
Model / Reference: BC21090 FDA UDI
Description: An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08697645010550 FDA UDI
FDA Product Code: CAI FDA UDI
GMDN Term: Ventilator 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

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: Ventilator breathing circuit, single-use

Standard Breathing Circuit with Trach by Meditera Tibbi Malzeme Sanayi Ve Ticaret Anonim Sirketi — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Ventilator breathing circuit, single-use.

HUDSON RCI — TELEFLEX INCORPORATED · Class II
MEDIFLEX — Mediflex Medikal · Class IIa
ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class II
AirLife™ — Airlife, Inc. · Class II
Classic RT — Plastiflex Group NV · 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 I	Pending data

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

Manufacturer

Manufacturer: Meditera Tibbi Malzeme Sanayi Ve Ticaret Anonim Sirketi

Sources (1)

FDA UDI 68a9c55c-fc71-4824-b1f6-4ace936f2099 34 fields · synced May 30, 2026