Duns Number:066175613
Device Description: ACCU-TEMP PROBE #230 FOR USE W/OHMEDAw/hydrogel 175 probe cover
Catalog Number
230H
Brand Name
AccuTemp Probe
Version/Model Number
230H
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
K960080,K960080
Product Code
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
5d7e5ecd-6b51-472c-9478-4fe7734b4321
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 02, 2016
Package DI Number
20817522010219
Quantity per Package
10
Contains DI Package
10817522010212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |