Duns Number:612746933
Catalog Number
-
Brand Name
Infinity 500mL Feeding Bag Set with Enfit Connector
Version/Model Number
INF0500-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
eb29dd82-5f7a-467d-9f67-404a0d0b80dd
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 13, 2021
Package DI Number
30814844000260
Quantity per Package
30
Contains DI Package
10814844000266
Package Discontinue Date
-
Package Status
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 |