AmeriWater 00BCM100

GUDID 00817927020291

00BCM100 Manual Mix and Dispense Bicarb, 100 Gallon

AMERIWATER, LLC

Haemodialysis system bicarbonate mixer

• Primary Device ID: 00817927020291
• NIH Device Record Key: 3a41d2c7-caf7-4a73-a254-fc0ae8b63a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmeriWater 00BCM100
• Version Model Number: 00BCM100
• Company DUNS: 836758342
• Company Name: AMERIWATER, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Dimensions

• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound
• Width: 49 Inch
• Depth: 35 Inch
• Height: 59 Inch
• Weight: 195 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817927020291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051031

FDA Product Code

• FIN: Tank, Holding, Dialysis

Sterilization

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

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

[00817927020291]

Liquid Chemical;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-10

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