Duns Number:006961700
Catalog Number
-
Brand Name
up&up
Version/Model Number
MT19U1-TG (#094060024)
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"
-
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
1e465aff-55b6-49d6-b975-c4969f1cabc6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2017
Package DI Number
20642632760101
Quantity per Package
12
Contains DI Package
10642632760104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box packing
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |
U | Unclassified | 12 |