Duns Number:007941230
Device Description: Kit IV Start Tegaderm 2.375 X 2.75 Inch Alcohol Prep Pad 2 Percent Tincture Of Iodine 2 X Kit IV Start Tegaderm 2.375 X 2.75 Inch Alcohol Prep Pad 2 Percent Tincture Of Iodine 2 X 2 Inch Gauze 0.75 X 18 Inch Transpore Tape 0.75 X 18 Inch Rolled Tourniquet 1 Pair Gloves Label Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
IVS1012B
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
e6bb2215-748c-4fd6-9eb7-22fa87bf395a
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
50885632136908
Quantity per Package
50
Contains DI Package
10885632136900
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |