Duns Number:001695568
Device Description: AAFES EXCH SELECT INFRARED THERMOMETER
Catalog Number
150-935-000
Brand Name
Exchange Select
Version/Model Number
150-935-000
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
-
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
K100488,K100488,K100488
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
31aa36ff-afe1-4cdb-bf0f-e6b7613893ef
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
10614299013473
Quantity per Package
8
Contains DI Package
30614299013477
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |