AccessGUDID - DEVICE: UNICO POWERSPIN BX (00816668020096)

GUDID

Device Identifier (DI) Information

Brand Name: UNICO POWERSPIN BX
Version or Model: C885
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C885
Company Name: UNITED PRODUCTS & INSTRUMENTS

Primary DI Number: 00816668020096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796269165 *Terms of Use

Device Description: POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLACE MICROHEMATOCRIT ROTOR AND 24 PLACE MICROCENTRIFUGE ROTOR, 110 V

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: d8aef4af-388c-4d18-9bfa-557ad6145ac3
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: April 10, 2017