Duns Number:080160207
Device Description: IV Start Kit w/18ga Safety Cath
Catalog Number
4818-62502
Brand Name
easycare
Version/Model Number
4818-62502
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
8c9928d7-c0d3-4e1c-ae74-3f228fca42bc
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 2020
Package DI Number
00850015884269
Quantity per Package
100
Contains DI Package
00850015884252
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |