Duns Number:007941230
Device Description: Kit Iv Start Chloraprep Sepp Tegaderm 2 3/8X2 3/4In 2X2In Non-Woven Gauze 3/4X18In Rolled Kit Iv Start Chloraprep Sepp Tegaderm 2 3/8X2 3/4In 2X2In Non-Woven Gauze 3/4X18In Rolled Tourniquet 3/4X24In Transpore Tape Label Latex-Free Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
IVS1043
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
cf8418e0-0d74-40ca-aa2e-ede3072f96fc
Public Version Date
October 20, 2020
Public Version Number
1
DI Record Publish Date
October 12, 2020
Package DI Number
50885632113510
Quantity per Package
100
Contains DI Package
10885632113512
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 |