AccessGUDID - DEVICE: Automated Digital Morphology Analyzer DI-60 (07350040972021)

GUDID

Device Identifier (DI) Information

Brand Name: Automated Digital Morphology Analyzer DI-60
Version or Model: CC286297
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC286297
Company Name: Cellavision AB

Primary DI Number: 07350040972021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 508663101 *Terms of Use

Device Description: Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears

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?
61864	Cell morphology analyser IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell
JOY	Device, Automated Cell-Locating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092868	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: 94bd167b-12d7-4bdb-8171-db4ac2542d1a
Public Version Date: September 16, 2022
Public Version Number: 5
DI Record Publish Date: September 20, 2016