Duns Number:192135242
Device Description: PMI Huber Safety Infusion Set 22G x ¾” Needle, Needle-Free Y-Site, 8" Tubin
Catalog Number
-
Brand Name
PMI
Version/Model Number
PMI223YES
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0548f96e-c197-4c1c-8545-2decc90ac2a0
Public Version Date
April 04, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10812608021076
Quantity per Package
12
Contains DI Package
00812608021079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |