Duns Number:007941230
Device Description: Kit IV Start Includes 1 Flex Blister With Lid 1 Tegaderm Dressing 2.5X2.75 2 Gauze 2X2 1 Kit IV Start Includes 1 Flex Blister With Lid 1 Tegaderm Dressing 2.5X2.75 2 Gauze 2X2 1 Chloraprep Frepp Insert 1 Chloraprep Frepp 1.5ml Applicator 1 Tourniquet 0.75X18 Rolled 1 Transpore Tape Roll 0.75X36 Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
IVS2062
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
89076c6a-7c94-43a7-91a4-0bf8994ae89a
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
50885632136748
Quantity per Package
50
Contains DI Package
10885632136740
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 |