Duns Number:170301969
Device Description: 1058 IV SET, STERILE DISP, EXTENSION SET
Catalog Number
IVP1058
Brand Name
Iradimed
Version/Model Number
1058
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K050301,K050301
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
d5e591ba-13ff-499b-8e90-910b5472f5df
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 25, 2016
Package DI Number
10856038001055
Quantity per Package
50
Contains DI Package
00856038001058
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |