Duns Number:831375089
Device Description: Standard IV Start Kit: Tegaderm™ 1614, IV Change Label, ChloraPrep® Frepp® 1.5ml, 2"x2" 4- Standard IV Start Kit: Tegaderm™ 1614, IV Change Label, ChloraPrep® Frepp® 1.5ml, 2"x2" 4-ply Gauze, Transpore™ Tape .75"x18", Orange Tourniquet .75"x18"
Catalog Number
7243
Brand Name
PremierPro
Version/Model Number
7243
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
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
ffd41153-2992-4cdc-b69c-a0bafe13bd98
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 29, 2020
Package DI Number
10818566016895
Quantity per Package
100
Contains DI Package
00818566016898
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |