Duns Number:618825723
Device Description: KENTEK FINGER PULSE OXIMETER WITH LED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PU KENTEK FINGER PULSE OXIMETER WITH LED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF.
Catalog Number
KT-1000
Brand Name
KenTeK
Version/Model Number
KT-1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K141105
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
a3c9ad71-952d-4da4-b11d-9871ce2fa7b4
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
November 18, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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. | 155 |