Duns Number:007941230
Device Description: Kit Iv Start Chlorascrub Pad Tegaderm 2 3/8X2 3/4In 2X2In Gauze 1X18In Tourniquet 3/4X18In Kit Iv Start Chlorascrub Pad Tegaderm 2 3/8X2 3/4In 2X2In Gauze 1X18In Tourniquet 3/4X18In Transpore Tape Label Latex-Free Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
IVS8003
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
K923361,K923361
Product Code
LRS
Product Code Name
I.V. start kit
Public Device Record Key
7aa241db-5b06-40c7-a409-5c3933d72c23
Public Version Date
October 20, 2020
Public Version Number
1
DI Record Publish Date
October 12, 2020
Package DI Number
50885632114036
Quantity per Package
50
Contains DI Package
10885632114038
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 |