Duns Number:080113296
Device Description: Care Touch U-100 Insulin Syinges30g 5/16"-8mm 1cc
Catalog Number
-
Brand Name
Care Touch
Version/Model Number
IS301
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152808,K152808,K152808
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
a62710a1-32f4-4726-9d50-77384107c5d6
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
March 07, 2017
Package DI Number
10370393302010
Quantity per Package
5
Contains DI Package
00370393302013
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |