AccessGUDID - DEVICE: Maky 21.1 (00898021000037)

GUDID

Device Identifier (DI) Information

Brand Name: Maky 21.1
Version or Model: 21.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAKY21.1
Company Name: Angelini Pharma Inc.

Primary DI Number: 00898021000037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078843940 *Terms of Use

Device Description: Dialyzer reprocessing machine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33888	Haemodialysis dialyser reprocessing system	An assembly of mains electricity (AC-powered) devices designed to clean and disinfect haemodialysis dialyzers after each use so that they can be reused, usually by the same patient. It typically performs a cycle that includes rinsing the dialyser with water/cleaning agent [e.g., hydrogen peroxide (H2O2)]; reverse ultrafiltration cleaning; disinfection or re-sterilization (e.g., with formaldehyde); labelling; and performance testing (e.g., volume, pressure). The complete cycle may be performed on one dialyser at a time or several at once (i.e., a single- or multiple-station system). The system may include computing capabilities or be attached to a personal computer for operation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIF	Dialyzer Reprocessing System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024076	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 615b7242-ee00-4a02-aeec-5ed38c40b857
Public Version Date: February 15, 2023
Public Version Number: 4
DI Record Publish Date: August 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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