TDS Standard Solution 02.0077

GUDID M985020583

Total Dissolved Solids Solution 150ppm 229uS/cm 1Pt

MESA LABORATORIES, INC.

Haemodialysis conductivity standard solution

• Primary Device ID: M985020583
• NIH Device Record Key: a91e9d34-31cf-4b30-9f8b-c6c517a796a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TDS Standard Solution
• Version Model Number: 02.0077
• Catalog Number: 02.0077
• Company DUNS: 102530326
• Company Name: MESA LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M985020077 [Primary]
HIBCC	M985020583 [Package]; Contains: M985020077; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191496

FDA Product Code

• FKH: Solution-Test Standard-Conductivity, Dialysis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [TDS Standard Solution]

• M985020583: Total Dissolved Solids Solution 150ppm 229uS/cm 1Pt
• M985020582: Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Pt
• M985020081: Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Qt
• M985020080: Total Dissolved Solids Solution 150ppm 229uS/cm 1Qt
• M985020079: Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Qt