AccessGUDID - DEVICE: ONE MAN KIT OKA 2511-1 (05713494002690)

GUDID

Device Identifier (DI) Information

Brand Name: ONE MAN KIT OKA 2511-1
Version or Model: 504-37v01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504-37
Company Name: Eldon Biologicals A/S

Primary DI Number: 05713494002690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 307910120 *Terms of Use

Device Description: For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.

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:	Yes
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?
45308	ABO/Rh multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K790282	000

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
Handling Environment Temperature: between 5 and 37 Degrees Celsius
Storage Environment Temperature: between 5 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43cf0679-5074-48cc-bac3-c0ee1f650d76
Public Version Date: July 15, 2024
Public Version Number: 1
DI Record Publish Date: July 05, 2024