HACH 9746600

GUDID 00851575007273

PERFORMANCE CHECK KIT, CM130

HACH COMPANY

Haemodialysis system chlorine monitor

• Primary Device ID: 00851575007273
• NIH Device Record Key: d81514a6-746f-49fe-9cb0-01e788f83fae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HACH
• Version Model Number: 9746600
• Catalog Number: 9746600
• Company DUNS: 091381780
• Company Name: HACH COMPANY
• 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: true
• 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

Customer Support Contacts

• Phone: 800-227-4224
• Email: orders@hach.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162471

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-05-12

On-Brand Devices [HACH]

• 00851575007365: MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365)
• 00851575007358: STIR MOTOR REPLACEMENT MODULE KIT
• 00851575007334: REAGENT DELIVERY MODULE REPLACEMENT KIT
• 00851575007310: SAMPLE CONDITIONING/SPEAKER MODULE REPLACEMENT KIT
• 00851575007297: ASSY, TUBING MAINTENANCE KIT, CM130
• 00851575007273: PERFORMANCE CHECK KIT, CM130
• 00851575007242: MONTHLY MAINTENANCE KIT, CM130
• 00851575007198: TOP LEVEL ASSY, CM130
• 00851575007181: REMOTE INDICATOR ASSY, CM130