Duns Number:053146767
Device Description: The SG 066-2N 1 liter latex-free reservoir bag is intended to be used with the SG 066 Oxyg 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.
Catalog Number
-
Brand Name
SG 066-2N 1 liter latex-free reservoir bag
Version/Model Number
SG 066-2N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTC
Product Code Name
Bag, Reservoir
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
Package DI Number
M996SG0662N4
Quantity per Package
25
Contains DI Package
M996SG0662N0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |