AccessGUDID - DEVICE: SG 066 Oxygen Enrichment Kit (M996SG0660)

GUDID

Device Identifier (DI) Information

Brand Name: SG 066 Oxygen Enrichment Kit
Version or Model: SG 066
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996SG0660
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46867	Oxygen administration enhancement device	A non-sterile device intended to be used to rapidly provide a supply of inhaled oxygen (O2) at higher than normal concentrations (e.g., FiO2 concentrations of 70% at 6L/min), typically for a patient during recovery [e.g., in the operating room (OR)]. It typically includes tubing that connects directly to an O2 source, a reservoir bag that concentrates the O2 and enables confirmation of respiration through its movement, a coupling that connects into an artificial airway already in situ, and a port for exhalation of gases. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992670	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c921910c-46f2-47ac-893b-73c17001e2b3
Public Version Date: September 16, 2021
Public Version Number: 6
DI Record Publish Date: October 24, 2015