AccessGUDID - DEVICE: ELDON HOME KIT HKA 2511-1 (05713494000054)

GUDID

Device Identifier (DI) Information

Brand Name: ELDON HOME KIT HKA 2511-1
Version or Model: 504-18v06
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 504-18
Company Name: Eldon Biologicals A/S

Primary DI Number: 05713494000054
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 307910120 *Terms of Use

Device Description: For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e01016b2-3615-4aa9-b452-4f4753acfc55
Public Version Date: December 05, 2022
Public Version Number: 5
DI Record Publish Date: September 07, 2016