Beckman Coulter® PK® Systems Bromelin 17330

GUDID 23661562173307

Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System

DIAGAST

Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD Bromelin immunohaematology reagent IVD

• Primary Device ID: 23661562173307
• NIH Device Record Key: 2e22ad18-2856-4f0e-a56e-b6825681c986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter® PK® Systems Bromelin
• Version Model Number: 17330
• Catalog Number: 17330
• Company DUNS: 381527001
• Company Name: DIAGAST
• Device Count: 6
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	13661562173300 [Unit of Use]
GS1	23661562173307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060024

FDA Product Code

• KSK: Solution, Stabilized Enzyme

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-18

Devices Manufactured by DIAGAST

• 23661562495584 - Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63): 2020-10-28 Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
• 23661562105261 - Anti-D (RH1) IgM+IgG: 2020-03-11 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to
• 23661562105445 - LISS: 2018-09-12 Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohemato
• 23661562105438 - Neg Control: 2018-07-06 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
• 23661562173178 - Beckman Coulter® PK® Systems Control: 2018-07-06 Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562173307 - Beckman Coulter® PK® Systems Bromelin: 2018-07-06Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562173307 - Beckman Coulter® PK® Systems Bromelin: 2018-07-06 Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562105209 - Anti-A (AB01): 2018-06-01 Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system
• 23661562105216 - Anti-B (AB02): 2018-06-01 Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system b