Duns Number:791014871
Device Description: Thermometer Probe Covers
Catalog Number
3211
Brand Name
Tech-Med
Version/Model Number
3211
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2020
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
K903590,K903590,K903590,K903590
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
15b763ea-7622-46d9-8f68-1802db2c1e89
Public Version Date
May 23, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20665973017093
Quantity per Package
12
Contains DI Package
10665973017096
Package Discontinue Date
October 14, 2020
Package Status
Not 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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 31 |
U | Unclassified | 1 |