Device
Conductivity Solution - NaCl, 1.0mS/cm, 16oz. (473mL) Cylinder
Manufacturer
Nipro Technical Solutions, Inc.
Nipro Technical Solutions, Inc.
Model: 10010
DI: 00850016976086
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Conductivity Solution - NaCl, 1.0mS/cm, 16oz. (473mL) Cylinder
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
271ed648-92d9-4f69-b48d-433867c7c167
Distribution Status:
In Commercial Distribution
DUNS Number:
139015999
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850016976086
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47678
Name: Haemodialysis conductivity standard solution
Definition:
A salt solution, typically salt dissolved in deionized/purified water, used to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. The solution is typically available in sealed plastic bottles and in a range of values and accuracies. It may be available over-the-counter. This is a single-use device.
FDA Product Codes
FKH
Solution-Test Standard-Conductivity, Dialysis
Premarket Submissions
Submission Number:
K041636
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
0
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Type:
Storage Environment Temperature