Duns Number:177667227
Device Description: 50 pack of probe covers. A device intended to be used as a physical barrier between the pa 50 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.
Catalog Number
-
Brand Name
Health Mart
Version/Model Number
K-955
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
9058a627-7b19-4698-8825-6677e5bc6c30
Public Version Date
June 11, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
40052569134779
Quantity per Package
8
Contains DI Package
20052569134775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |