Duns Number:557223252
Device Description: Flame photometer standard 140 Na 5K
Catalog Number
00009751750
Brand Name
Flame photometer standard 140 Na 5K
Version/Model Number
00009751750
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K823480,K823480
Product Code
JJO
Product Code Name
FLAME EMISSION PHOTOMETER FOR CLINICAL USE
Public Device Record Key
870083bb-0262-452f-b470-6d0bdc39e6d8
Public Version Date
July 07, 2021
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 272 |