AccessGUDID - DEVICE: ABX PENTRA DX 120 (03610230006375)

GUDID

Device Identifier (DI) Information

Brand Name: ABX PENTRA DX 120
Version or Model: 1280100084, 1280100085, 1280100086, 1280100088
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HORIBA ABX SAS

Primary DI Number: 03610230006375
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 273647420 *Terms of Use

Device Description: 100 or 110V, ready for SPS

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:	Yes
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?
35476	Haematological cell analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050719	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: 997431ac-0862-4d7c-a3be-0a12f7d5bdfd
Public Version Date: May 16, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2016