SAMI RRT Cassette SA-400-00

GUDID B173SA40000

The SAMI RRT Cassette 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.

Spectral Medical Inc

Haemodialysis blood tubing set, single-use

• Primary Device ID: B173SA40000
• NIH Device Record Key: 61eb8200-e8b8-440a-a6bc-2f2d2beb8939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMI RRT Cassette
• Version Model Number: SA-400-00
• Catalog Number: SA-400-00
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B173SA40000 [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: 6
• Public Version Date: 2019-11-22
• Device Publish Date: 2018-03-05

On-Brand Devices [SAMI RRT Cassette]

• B173SA40000: The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic f
• B173SA400000: The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic f