Duns Number:002397347
Device Description: 20 ML NORM-JECT LL BBRAUN AIR-TITE
Catalog Number
NJ-4606736-02
Brand Name
NORM-JECT®
Version/Model Number
NJ-4606736-02
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
305f88a0-9bda-4359-853d-d6da30cf492f
Public Version Date
March 16, 2020
Public Version Number
1
DI Record Publish Date
March 06, 2020
Package DI Number
04046955597222
Quantity per Package
8
Contains DI Package
04046955597215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |