Duns Number:107260002
Device Description: D-DP208-700HH Single Use Skin Temperature Probe
Catalog Number
D-DP208-700HH
Brand Name
Access Medical Probes
Version/Model Number
D-DP208-700HH
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
Product Code
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
58934a6b-7a6b-4fd3-9c31-e5ae110e5ec5
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 13, 2018
Package DI Number
10854758006190
Quantity per Package
25
Contains DI Package
00854758006193
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 |