Duns Number:797372554
Catalog Number
JD+01U3008-SB
Brand Name
NIPRO INSULIN SYRINGE
Version/Model Number
JD+01U3008-SB
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
6b5b702c-7499-4960-ab7f-411e4fe7a7d6
Public Version Date
November 09, 2020
Public Version Number
3
DI Record Publish Date
June 12, 2018
Package DI Number
40383790008783
Quantity per Package
36
Contains DI Package
10383790008782
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 230 |