AccessGUDID - DEVICE: UNICO POWERSPIN BX (00816668020010)

GUDID

Device Identifier (DI) Information

Brand Name: UNICO POWERSPIN BX
Version or Model: C882
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C882
Company Name: UNITED PRODUCTS & INSTRUMENTS

Primary DI Number: 00816668020010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796269165 *Terms of Use

Device Description: C882 Microhematocrit Centrifuge, 24 place rotor, electronic timer. 110V

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: 34fbb68f-181a-4bb9-b72f-64b790c37891
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: August 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (732)274-1155
Email: info@unicosci.com

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