AccessGUDID - DEVICE: AP 720S™ Semi-Automated Processor (00813382010211)

GUDID

Device Identifier (DI) Information

Brand Name: AP 720S™ Semi-Automated Processor
Version or Model: 93602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 93602
Company Name: Minaris Medical America, Inc.

Primary DI Number: 00813382010211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102113867 *Terms of Use

Device Description: AP 720S™ Semi-Automated 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?
56702	Chemiluminescent immunoassay analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DHB	System, test, radioallergosorbent (rast) immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112910	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: 991fc047-bbed-42a2-94a9-34b81d51b725
Public Version Date: April 11, 2022
Public Version Number: 4
DI Record Publish Date: December 08, 2017