AccessGUDID - DEVICE: Data-Cyte Plus 2 0.8% (07640137341459)

GUDID

Device Identifier (DI) Information

Brand Name: Data-Cyte Plus 2 0.8%
Version or Model: 11x4 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213641
Company Name: Medion Grifols Diagnostics AG

Primary DI Number: 07640137341459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483287020 *Terms of Use

Device Description: Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.

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:	Yes
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?
52543	Antibody identification panel reagent red blood cell IVD, kit, agglutination	A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 64655fb1-f9f7-4b65-8102-3a972529da46
Public Version Date: April 30, 2024
Public Version Number: 1
DI Record Publish Date: April 22, 2024