AccessGUDID - DEVICE: DG Spin (08437014205152)

GUDID

Device Identifier (DI) Information

Brand Name: DG Spin
Version or Model: 210363
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210363
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.

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):	Yes
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?
66230	Gel column agglutination centrifuge IVD	An electrically-powered device intended to be used in a clinical laboratory setting for the centrifugation of gel column agglutination cards used to perform manual blood typing assays. It is a dedicated compact benchtop unit with an electric motor, a shaft, a rotor with slots specifically shaped for use with gel column cards, and speed and time controls. The device is intended to centrifuge gel column agglutination cards for the manual determination of antigens of multiple blood systems (e.g., ABO, Rh, Kell) for compatibility testing and detection of unexpected antibodies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBC	Manual Blood Grouping And Antibody Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK120045	0

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: 1c363f4e-e112-4b87-b283-8c90a4498bb8
Public Version Date: April 29, 2025
Public Version Number: 4
DI Record Publish Date: September 06, 2016