Duns Number:612746933
Device Description: Enteralite Infinity Super Mini Backpack, Black
Catalog Number
50749-001
Brand Name
Infinity
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 03, 2021
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
8d5a974f-cb16-45bc-a3d2-4b6da5b7e33f
Public Version Date
May 07, 2021
Public Version Number
5
DI Record Publish Date
August 03, 2018
Package DI Number
38148440000136
Quantity per Package
3
Contains DI Package
18148440000132
Package Discontinue Date
March 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 |