Duns Number:612746933
Catalog Number
-
Brand Name
Enteral 1200 mL Gravity Feeding Bag
Version/Model Number
GR1200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 03, 2021
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"
-
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
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
ad945fe5-f790-4d1b-a982-78da7280507e
Public Version Date
November 04, 2021
Public Version Number
4
DI Record Publish Date
October 21, 2016
Package DI Number
38148440000839
Quantity per Package
30
Contains DI Package
18148440000835
Package Discontinue Date
November 03, 2021
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 106 |