Duns Number:605151018
Device Description: Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
Catalog Number
5116B
Brand Name
Serim® GUARDIAN™
Version/Model Number
5116B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2016
Issuing Agency
In HIBCC
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945491,K945491,K945491
Product Code
MNV
Product Code Name
Strip, Dialysate Ph Indicator
Public Device Record Key
4f39f95c-5bb3-4de3-8e8a-84b847f8ae97
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 29, 2016
Package DI Number
M1745116B2
Quantity per Package
5
Contains DI Package
M1745116B1
Package Discontinue Date
August 31, 2016
Package Status
Not in Commercial Distribution
Package Type
Kit