AccessGUDID - DEVICE: QBC Diagnostics (00858092006062)

GUDID

Device Identifier (DI) Information

Brand Name: QBC Diagnostics
Version or Model: 42574009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42574009
Company Name: DRUCKER DIAGNOSTICS

Primary DI Number: 00858092006062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022156957 *Terms of Use

Device Description: Refurbished QBC Centrifuge - Capillary Tube Centrifuge

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Microhaematocrit centrifuge	A tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

GMDN Preferred Term Name

GMDN Definition

Microhaematocrit centrifuge

A tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

FDA Product Code

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Product Code	Product Code Name
GKG	Centrifuge, Hematocrit

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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9f8dda9-8845-430c-97fb-91ff6fe4b938
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016