SAMI CRRT Unit SM-100-003

GUDID B173SM001

The SAMI CRRT Unit is a software controlled device that performs the following functions: - Primes the CRRT disposable cassette automatically. - Pumps

Spectral Medical Inc

Haemodialysis system, institutional

• Primary Device ID: B173SM001
• NIH Device Record Key: 46aced0a-6fa4-4248-a9bd-65d1d1b3898b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMI CRRT Unit
• Version Model Number: SM-100-003
• Catalog Number: SM-100-003
• Company DUNS: 248909939
• Company Name: Spectral Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 18884264264
• Email: gguadagni@spectraldx.com
• Phone: 18884264264
• Email: gguadagni@spectraldx.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B173SM001 [Primary]

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-15
• Device Publish Date: 2018-02-22

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