Cassette Hemofiltration SM-200-003

GUDID B173SMF200

The HF Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. The total length of the arterial and venous tubing lines are below: -Arterial patient connection line: 71 inches -Arterial dialyzer line: 20 inches -Venous patient connection line: 22 inches -Venous dialyzer line: 79 inches

Spectral Medical Inc

Haemodialysis blood tubing set, single-use

• Primary Device ID: B173SMF200
• NIH Device Record Key: 1b27faa6-75c4-4622-b8cd-b35bd78cb4e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cassette Hemofiltration
• Version Model Number: SM-200-003
• Catalog Number: SM-200-003
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 18884264264
• Email: gguadagni@spectraldx.com
• Phone: 18884264264
• Email: gguadagni@spectraldx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B173SMF200 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-02-22

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• B173SMF200 - Cassette Hemofiltration: 2019-06-07The HF Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. The total length of the arterial and venous tubing lines are below: -Arterial patient connection line: 71 inches -Arterial dialyzer line: 20 inches -Venous patient connection line: 22 inches -Venous dialyzer line: 79 inches
• B173SMF200 - Cassette Hemofiltration: 2019-06-07 The HF Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is ste