AccessGUDID - DEVICE: MX12 Centrifuge with 24-place hematocrit rotor (00664816003527)

GUDID

Device Identifier (DI) Information

Brand Name: MX12 Centrifuge with 24-place hematocrit rotor
Version or Model: MHC-24HD-75T1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LW SCIENTIFIC, INC.

Primary DI Number: 00664816003527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785335381 *Terms of Use

Device Description: MX12 Centrifuge; Digital, 24-place hematocrit (75mm), 12,000 rpm, reader disk, 110 volt

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?
32429	Microhaematocrit centrifuge IVD	An electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.	Active	false

FDA Product Code

[?]

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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c7f31b5-e721-4c37-b4fc-601ec39cee44
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: June 05, 2019