Duns Number:107260002
Device Description: T 11000 Single Use Skin Temperature Probe
Catalog Number
T 11000
Brand Name
Tarry Probes
Version/Model Number
T 11000
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
Yes
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
K071977,K071977,K071977
Product Code
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
41d029b8-f58e-4b39-bace-7005b7ba4215
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
20854758006043
Quantity per Package
100
Contains DI Package
00854758006049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |