AccessGUDID - DEVICE: HELMED (42601861205007)

GUDID

Device Identifier (DI) Information

Brand Name: HELMED
Version or Model: HELMED® IFA PROCESSOR KIT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HEL-1000
Company Name: Aesku.Systems GmbH & Co. KG

Primary DI Number: 42601861205007
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 341702675 *Terms of Use

Device Description: Automated IFA Processor

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?
61927	Multi-modality clinical specimen analysis system IVD	An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQW	Station, Pipetting And Diluting, For Clinical Use

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: 0f47130b-99d9-42cc-8e21-9bf92d70892e
Public Version Date: March 03, 2020
Public Version Number: 4
DI Record Publish Date: September 27, 2016