ELDONBOX 2511-100 100 ELDONCARD 2511

Basic Information

• Brand Name: ELDONBOX 2511-100 100 ELDONCARD 2511
• Primary DI: 05713494001785
• Version / Model: 404-02v06
• Catalog Number: 404-02
• Company Name: Eldon Biologicals A/S
• Labeler DUNS: 307910120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-11-04
• Public Version: 2
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: e26d8bf0-c3f9-4e2d-abac-8a9f2f1d8168

Device Description

For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screening purposes prior to transfusion. No para el uso para defender propósitos antes de la transfusión. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05713494000306	GS1
Primary	05713494001785	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K790282	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 37 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 37 Degrees Celsius