Duns Number:612746933
Device Description: Infinity 500 mL Feeding Bag Set with Enfit Connector
Catalog Number
INF0500-E
Brand Name
Infinity 500 mL Feeding Bag Set with Enfit Connector
Version/Model Number
INF0500-E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 27, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PIF
Product Code Name
Gastrointestinal Tubes With Enteral Specific Connectors
Public Device Record Key
a1a35228-bdd6-47bf-aac5-55dfa0d6513f
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
38148440001522
Quantity per Package
30
Contains DI Package
18148440001528
Package Discontinue Date
June 27, 2021
Package Status
Not in Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 106 |