Maky 21.1 MAKY21.1

GUDID 00898021000037

Dialyzer reprocessing machine.

Angelini Pharma Inc.

Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system Haemodialysis dialyser reprocessing system 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