Duns Number:009299017
Device Description: Note: KS2-SSLARGEUNSC is new part number for KS2SSLARGEUNSCE. Product did not change.
Catalog Number
KS2-SSLARGEUNSC
Brand Name
SAFE SEDATE®
Version/Model Number
KS2-SSLARGEUNSC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
MASK, GAS, ANESTHETIC
Public Device Record Key
19f2aeae-a763-4880-9946-55405308a5b8
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
Package DI Number
00612649176093
Quantity per Package
12
Contains DI Package
00612649205014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |