Duns Number:058027475
Device Description: NICU Medication Administration Set
Catalog Number
-
Brand Name
IMA
Version/Model Number
BC 274
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"
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
31ecdec7-aede-4473-81e1-56fe587b5718
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
May 31, 2019
Package DI Number
00813153022573
Quantity per Package
1
Contains DI Package
10813153022570
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. | 381 |