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TDS Standard Solution

FDA UDI

Class II (US FDA UDI)

by Mesa Laboratories, Inc.

Identity

Trade Name
TDS Standard Solution FDA UDI
Generic Name
Haemodialysis conductivity standard solution FDA UDI
Device Name
Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Pt FDA UDI
Model / Reference
02.0078 FDA UDI
Description
Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Pt FDA UDI

Identifiers

Catalog Number
02.0078 FDA UDI
Primary DI / UDI-DI
M985020078 FDA UDI
510(k) Number
K191496 FDA UDI
FDA Product Code
FKH FDA UDI
GMDN Term
Haemodialysis conductivity standard solution FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemodialysis conductivity standard solution

TDS Standard Solution by Mesa Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis conductivity standard solution.

Cleared under the same submission

K191496 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mesa Laboratories, Inc.

Sources (1)

  • FDA UDI 3b94faf0-b73d-4f73-a86e-be28c04f4815 35 fields · synced May 29, 2026