Duns Number:797372554
Catalog Number
NM+21G38-1M
Brand Name
NIPRO BLOOD COLLECTION NEEDLE
Version/Model Number
NM+21G38
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
f662e4f2-6433-41e0-8542-d06971bef4bc
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
20383790002435
Quantity per Package
10
Contains DI Package
10383790002438
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 |