Grifols Diluent 213677

GUDID 08437014205244

Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.

DIAGNOSTIC GRIFOLS SA

Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

• Primary Device ID: 08437014205244
• NIH Device Record Key: b23ad7ee-6601-46ee-bd2f-5eaf0572e104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grifols Diluent
• Version Model Number: 213677
• Catalog Number: 213677
• Company DUNS: 463625602
• Company Name: DIAGNOSTIC GRIFOLS SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205244 [Primary]
GS1	08437014205251 [Package]; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK120044

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-02
• Device Publish Date: 2016-09-06

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

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• 08437014205244 - Grifols Diluent: 2023-06-02Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.
• 08437014205244 - Grifols Diluent: 2023-06-02 Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.
• 08436583730980 - Blood Typing Manager: 2022-12-01 Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology
• 08436583731024 - DG Gel 8 Anti-D: 2022-10-18 The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. F
• 08436583731031 - DG Gel 8 Anti-AB: 2022-10-18 The DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human bl
• 08436583731055 - DG Gel 8 Anti-C: 2022-10-18 For the determination of human C antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08436583731062 - DG Gel 8 Anti-E: 2022-10-18 For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08436583731079 - DG Gel 8 Anti-c: 2022-10-18 For the determination of human c antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel