Duns Number:016069284
Device Description: Pressure Activated Safety Heelstick Lancet
Catalog Number
1004
Brand Name
MediHeel
Version/Model Number
1004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 01, 2025
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
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
6070485c-49fa-4496-be03-ce3bc7e7772a
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 01, 2020
Package DI Number
20732671210047
Quantity per Package
10
Contains DI Package
00732671010049
Package Discontinue Date
June 01, 2025
Package Status
In Commercial Distribution
Package Type
Corrugate Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |