Duns Number:007941230
Device Description: Kit Iv Start Tegaderm 2 3/8X2 3/4In 10X13In Drape Alcohol Preparation Pad Pvp Preparation Kit Iv Start Tegaderm 2 3/8X2 3/4In 10X13In Drape Alcohol Preparation Pad Pvp Preparation Pad 2X2In Gauze 3/4X18In Rolled Tourniquet 3/4X18In Transpore Tape Label Latex-Free Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
IVS1013
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
99192aff-a688-4109-a7e8-3b004a951ace
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
50885632113350
Quantity per Package
50
Contains DI Package
10885632113352
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 |