AccessGUDID - DEVICE: SG 066-2N 1 liter latex-free reservoir bag (M996SG0662N0)

GUDID

Device Identifier (DI) Information

Brand Name: SG 066-2N 1 liter latex-free reservoir bag
Version or Model: SG 066-2N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996SG0662N0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The SG 066-2N 1 liter latex-free reservoir bag is intended to be used with the SG 066 Oxygen Enrichment Kit, while in 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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
34877	Breathing circuit bag, single-use	A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTC	Bag, Reservoir

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 4ce410a3-4f81-4c87-ad13-c27370d47fa7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015