Maky 21.1 MAKY21.1

GUDID 00898021000037

Dialyzer reprocessing machine.

Angelini Pharma Inc.

Haemodialysis dialyser reprocessing system
Primary Device ID00898021000037
NIH Device Record Key615b7242-ee00-4a02-aeec-5ed38c40b857
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaky 21.1
Version Model Number21.1
Catalog NumberMAKY21.1
Company DUNS078843940
Company NameAngelini Pharma Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100898021000037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIFDialyzer Reprocessing System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-02-15
Device Publish Date2016-08-29

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 21.12023-02-15Dialyzer reprocessing machine.
00898021000037 - Maky 21.12023-02-15 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 - PeraSidual2023-02-15 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis

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