Duns Number:058810771
Device Description: IV Starter Kit - BD 22G Insyte Catheter, ICU Medical Bravo Connector, 5mm Saline Flush, IV Starter Kit - BD 22G Insyte Catheter, ICU Medical Bravo Connector, 5mm Saline Flush, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad
Catalog Number
2533-22G
Brand Name
Direct IV Solutions - IV Start Kit
Version/Model Number
2533-22G
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)
Yes
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
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
821f00a1-d8e4-4c43-8d4e-9931d550f2b3
Public Version Date
May 01, 2020
Public Version Number
1
DI Record Publish Date
April 23, 2020
Package DI Number
10851491007514
Quantity per Package
100
Contains DI Package
00851491007517
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |