Duns Number:542345014
Device Description: The Disposable Thermometer Covers and Sheaths are intended for use as barriers between dig The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
Catalog Number
-
Brand Name
Disposable Thermometer Cover and Sheaths
Version/Model Number
9225
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
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
K112289,K112289
Product Code
FLK
Product Code Name
Thermometer, Clinical Mercury
Public Device Record Key
104b209c-a794-4f3d-bac2-a77a26191b97
Public Version Date
September 02, 2019
Public Version Number
1
DI Record Publish Date
August 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-