Maky 21.1 MAKY21.1

GUDID 00898021000037

Dialyzer reprocessing machine.

Angelini Pharma Inc.

Haemodialysis dialyser reprocessing system

• Primary Device ID: 00898021000037
• NIH Device Record Key: 615b7242-ee00-4a02-aeec-5ed38c40b857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maky 21.1
• Version Model Number: 21.1
• Catalog Number: MAKY21.1
• Company DUNS: 078843940
• Company Name: Angelini Pharma Inc.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com
• Phone: 1-800-726-2308
• Email: customerservice@angelini-us.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00898021000037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024076

FDA Product Code

• LIF: Dialyzer Reprocessing 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: 4
• Public Version Date: 2023-02-15
• Device Publish Date: 2016-08-29

Devices Manufactured by Angelini Pharma Inc.

• 20898021000383 - Peracidin®: 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
• 20898021000406 - Peracidin®: 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
• 00898021000419 - Peracidin®: 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
• 00898021000037 - Maky 21.1: 2023-02-15Dialyzer reprocessing machine.
• 00898021000037 - Maky 21.1: 2023-02-15 Dialyzer reprocessing machine.
• 00898021000181 - Peracidin™: 2023-02-15 PAA Dialyzer Disinfectant.
• 00898021000228 - Peracidin™: 2023-02-15 PAA Dialyzer Disinfectant.
• 00898021000204 - Peracidin™: 2023-02-15 PAA Dialyzer Disinfectant.
• 00898021000235 - PeraSidual: 2023-02-15 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis