Duns Number:180572216
Device Description: Needle, 19G X 1 1/2"; 25 PCS/BOX, 100 PCS/CASE, 10CS/CRTN
Catalog Number
26474
Brand Name
EXEL BLUNT TIP ALUMINUM STERILE HUB NEEDLE
Version/Model Number
26474
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
K101309,K101309,K101309,K101309
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
5a5aea6e-9391-4996-8fe7-9961eccadbc8
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2019
Package DI Number
30020221264747
Quantity per Package
10
Contains DI Package
20020221264740
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |