Duns Number:832426782
Device Description: KIT, SUCTION DEVICE, TACTICAL HAND HELD
Catalog Number
10-0018
Brand Name
NAR TACTICAL SUCTION DEVICE
Version/Model Number
10-0018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSY
Product Code Name
Catheters, Suction, Tracheobronchial
Public Device Record Key
465287c1-eee8-46c2-9815-04c2aefc7741
Public Version Date
August 20, 2019
Public Version Number
1
DI Record Publish Date
August 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |