Duns Number:797372554
Catalog Number
-
Brand Name
NIPRO SOLUTION INFUSION SET
Version/Model Number
IS-01-A/A-21G/NV
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
K101958,K101958,K101958
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
6297c72c-b9d6-4fc3-a12c-8c3dd2d9f00b
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
10383790005743
Quantity per Package
100
Contains DI Package
00383790005746
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. | 230 |