AccessGUDID - DEVICE: APAS Independence (09354646000001)

GUDID

Device Identifier (DI) Information

Brand Name: APAS Independence
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AI-16001
Company Name: Clever Culture Systems AG

Primary DI Number: 09354646000001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487097888 *Terms of Use

Device Description: The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.

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):	Yes
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?
64148	Microbial culture plate imaging/analysis system IVD	An electrically-powered device intended to be used for the imaging and assessment of pre-inoculated, pre-incubated microbial culture plates. It typically consists of a sample handling/preparation unit, digital camera, optical reader, transfer unit and dedicated software for image capture, processing and/or analysis. It is not intended for incubation. The system may be a single self-contained unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPU	Microbial Colony Image Assessment System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183648	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: 19f5f5a7-c60f-438d-92a8-88df6c95ba68
Public Version Date: March 31, 2020
Public Version Number: 1
DI Record Publish Date: March 23, 2020