AccessGUDID - DEVICE: Maxibios (G0602024M0)

GUDID

Device Identifier (DI) Information

Brand Name: Maxibios
Version or Model: hub
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2024.m
Company Name: Amil Care Corp.

Primary DI Number: G0602024M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082275360 *Terms of Use

Device Description: Diffuser of ready-to-use liquid solutions

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?
58215	Airborne device-disinfectant diffuser	A mains electricity (AC-powered) mobile device designed for the automated dispersion of an appropriate disinfectant [e.g., formaldehyde, hydrogen peroxide (H2O2)] into the atmosphere of an enclosed area [e.g., operating room (OR), examination/treatment room] to destroy harmful microorganisms or inhibit their activity on the surfaces of medical devices and equipment after they have been exposed to microbial contamination (bacteria, fungi, viruses, spores of bacteria). It typically consists of a programmable aerosol electrical generator, user controls, tubing and connectors, and a recess for holding a prefilled canister of the disinfectant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: cf6aa0ed-0825-4d84-947c-f0a4ff98591d
Public Version Date: December 12, 2023
Public Version Number: 1
DI Record Publish Date: December 04, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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