Omnistream

FDA UDI

Class II (US FDA UDI)

by Oridion Medical 1987 Ltd.

Identity

Trade Name: Omnistream FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: SMART OMNILINE PLUS 02 ADULT 1UN FDA UDI
Model / Reference: 015772 FDA UDI
Description: SMART OMNILINE PLUS 02 ADULT 1UN FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521551947 FDA UDI
510(k) Number: K013845 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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

Omnistream by Oridion Medical 1987 Ltd. — 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
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Dispo-Med CO2 Sampling Line, MLL, W/Filter — DISPO-MED (MALAYSIA) SDN. BHD. · Class II
Gas Sampling Lines — SALTER LABS · Class II
Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
AirLife™ — Airlife, Inc. · Class II
Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 10FT — DISPO-MED (MALAYSIA) SDN. BHD. · Class II

Cleared under the same submission

K013845 also covers:

Surestream — ORIDION MEDICAL 1987 LTD.

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: Oridion Medical 1987 Ltd.

Sources (1)

FDA UDI 35bb9388-f696-44d3-8155-499d2428b120 35 fields · synced May 30, 2026