Duns Number:824763358
Device Description: 3 x Embrace TALK Monitor12 x Embrace TALK Test Strip 50ct.
Catalog Number
-
Brand Name
HealthWise Embrace TALK Pre-Pack (3x12)
Version/Model Number
APX03AB0312HWPR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090043
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
87b07705-1b93-465a-aeca-223ee0b6ba1a
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |