Duns Number:058614483
Device Description: Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective o Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective owners.
Catalog Number
-
Brand Name
Mon-a-Therm
Version/Model Number
502-0401A
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"
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
K895875,K895875
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
334f7475-a65a-46d7-9331-bf55b49f07b6
Public Version Date
May 04, 2022
Public Version Number
2
DI Record Publish Date
February 21, 2019
Package DI Number
10884521706408
Quantity per Package
40
Contains DI Package
10884521169289
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |