Duns Number:024502047
Device Description: 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" po 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc
Catalog Number
-
Brand Name
Infusion Safety Products, Inc.
Version/Model Number
ISP191Y
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
K170881,K170881
Product Code
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
e9f380f0-b73a-41d9-8c1a-cfa195076618
Public Version Date
February 26, 2020
Public Version Number
3
DI Record Publish Date
July 20, 2018
Package DI Number
10856673008143
Quantity per Package
25
Contains DI Package
00856673008146
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. | 6 |