Duns Number:080521945
Catalog Number
-
Brand Name
AMPMED
Version/Model Number
AMPW1W
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180207
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
dbf5982e-b943-48ae-b86b-9d0ac6114e28
Public Version Date
May 14, 2021
Public Version Number
1
DI Record Publish Date
May 06, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 30 |