Duns Number:308667539
Device Description: S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Catalog Number
944-136
Brand Name
S8377 REF 944-136 *6 Cleaning solution Met II Solution
Version/Model Number
944-136
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
37942c5c-0aeb-4b7d-8883-e5fa06cf2021
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
Package DI Number
15700699441369
Quantity per Package
6
Contains DI Package
05700699441362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 66 |