SG 066 Oxygen Enrichment Kit

GUDID M996SG0660

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.

INSTRUMENTATION INDUSTRIES, INCORPORATED

Respiratory gas output switch

• Primary Device ID: M996SG0660
• NIH Device Record Key: c921910c-46f2-47ac-893b-73c17001e2b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SG 066 Oxygen Enrichment Kit
• Version Model Number: SG 066
• Company DUNS: 053146767
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 412-854-1133
• Email: raqa@iiimedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M996SG0660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992670

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M996SG0660]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-04
• Device Publish Date: 2015-10-24

Devices Manufactured by INSTRUMENTATION INDUSTRIES, INCORPORATED

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• M996SH74BK5 - SH 74-BK Barbed Tubing Adapter: 2024-02-05 The SH 74-BK Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patie
• M996SH74BL5 - SH 74-BL Barbed Tubing Adapter: 2024-02-05 The SH 74-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patie
• M996SH74C5 - SH 74-C Barbed Tubing Adapter: 2024-02-05 The SH 74-C Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patien
• M996SH74G5 - SH 74-G Barbed Tubing Adapter: 2024-02-05 The SH 74-G Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patien
• M996SH74W5 - SH 74-W Barbed Tubing Adapter: 2024-02-05 The SH 74-W Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patien
• M996SH74Y5 - SH 74-Y Barbed Tubing Adapter: 2024-02-05 The SH 74-Y Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patien