Duns Number:928998905
Device Description: Lightweight portable continuous temperature monitor used to measure human body temperature Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).
Catalog Number
501501
Brand Name
DataTherm II
Version/Model Number
Datatherm II
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070878,K070878
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
adf690e9-544b-408f-9ddc-8480d9f57103
Public Version Date
May 07, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
16148015015013
Quantity per Package
1
Contains DI Package
00614801150118
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Hard Black Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |