Duns Number:170199058
Device Description: Hydrocolloid Blister Cushion, all one size, 1.65 IN x 2.67 IN (42 mm x 68 mm)
Catalog Number
-
Brand Name
CareOne
Version/Model Number
041520104861
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2021
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
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
995ce6fe-6983-4bed-83b7-2f42c51ddc01
Public Version Date
August 17, 2021
Public Version Number
4
DI Record Publish Date
July 31, 2019
Package DI Number
10041520104868
Quantity per Package
24
Contains DI Package
00041520104861
Package Discontinue Date
January 07, 2021
Package Status
Not 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 2 |