TDS Standard Solution 02.0076

GUDID M985020582

Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Pt

MESA LABORATORIES, INC.

Haemodialysis conductivity standard solution Haemodialysis conductivity standard solution
Primary Device IDM985020582
NIH Device Record Keyec71606e-3e12-4065-a3c2-55fd0a4f9627
Commercial Distribution StatusIn Commercial Distribution
Brand NameTDS Standard Solution
Version Model Number02.0076
Catalog Number02.0076
Company DUNS102530326
Company NameMESA LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM985020076 [Primary]
HIBCCM985020582 [Package]
Contains: M985020076
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKHSolution-Test Standard-Conductivity, Dialysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

On-Brand Devices [TDS Standard Solution]

M985020583Total Dissolved Solids Solution 150ppm 229uS/cm 1Pt
M985020582Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Pt
M985020081Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Qt
M985020080Total Dissolved Solids Solution 150ppm 229uS/cm 1Qt
M985020079Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Qt

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