Duns Number:044611812
Device Description: Feeding/D-Comp
Catalog Number
000395
Brand Name
Feeding/Decompression Tube
Version/Model Number
000395
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2016
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
5d8dd259-8d88-493b-bd5d-ac1cbed45c73
Public Version Date
April 12, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
10801741081061
Quantity per Package
12
Contains DI Package
00801741081064
Package Discontinue Date
June 27, 2016
Package Status
Not in Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |