Duns Number:612746933
Device Description: Enteralite Infinity Adult Pack, Black
Catalog Number
50753
Brand Name
Infinity
Version/Model Number
Infinity Adult Pack, Black
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
LZH
Product Code Name
Pump, Infusion, Enteral
Public Device Record Key
b73f1b28-d7b6-4d74-b480-2602d016cf78
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 106 |