AccessGUDID - DEVICE: Diamedix (00817273020464)

GUDID

Device Identifier (DI) Information

Brand Name: Diamedix
Version or Model: MAGO Plus
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DIAMEDIX CORPORATION

Primary DI Number: 00817273020464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151765328 *Terms of Use

Device Description: MAGO Plus chemistry analyzer

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?
56680	Multichannel clinical chemistry analyser IVD, point-of-care, line-powered	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, metabolites, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, enzymatic chemistry, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJF	Analyzer, Chemistry, Micro, For Clinical Use

FDA Premarket Submission

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

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
Handling Environment Temperature: between 18 and 30 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2fe1050e-f1b4-45cb-ae67-7914e50870ba
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 305-324-2300
Email: customerservice@erbadiagnostics.com

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