HACH 9638600

GUDID 00851575007198

TOP LEVEL ASSY, CM130

HACH COMPANY

Haemodialysis system chlorine monitor

• Primary Device ID: 00851575007198
• NIH Device Record Key: 0a22f752-eec1-4861-a6dd-30302559d492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HACH
• Version Model Number: 9638600
• Catalog Number: 9638600
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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 -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007198 [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: 3
• Public Version Date: 2018-07-06
• 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