Duns Number:080160207
Device Description: IV Start Kit w/3M™ Tegaderm™ #1624 & PDI Prevantics® Swab
Catalog Number
4502-50000
Brand Name
easycare
Version/Model Number
4502-50000
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
02bc52d1-10d1-49d8-9449-482ccebef178
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 17, 2020
Package DI Number
00850015884153
Quantity per Package
100
Contains DI Package
00850015884115
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |