SG 066 Oxygen Enrichment Kit

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: SG 066 Oxygen Enrichment Kit FDA UDI
Generic Name: Oxygen administration enhancement device FDA UDI
Device Name: The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway. FDA UDI
Model / Reference: SG 066 FDA UDI
Description: The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway. FDA UDI

Identifiers

Primary DI / UDI-DI: M996SG0660 FDA UDI
510(k) Number: K992670 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Oxygen administration enhancement device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

High-level Disinfectant FDA UDI

Category: Oxygen administration enhancement device

SG 066 Oxygen Enrichment Kit by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen administration enhancement device.

Nasal Oxygen Cannula — DISTRIBUTION UNLIMITED, LLC · 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: Instrumentation Industries, Incorporated

Sources (1)

FDA UDI c921910c-46f2-47ac-893b-73c17001e2b3 35 fields · synced May 31, 2026