SP B3158-1

GUDID 20630140008501

Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro Diagnostic Use Only; Not for Infusion, Injection, or Irrigation; 20 liters

Cardinal Health 200, LLC

Red cell antibody diluent IVD, reagent

• Primary Device ID: 20630140008501
• NIH Device Record Key: e160cc87-fe45-4c65-a4f0-7453ec2f8ba2
• Commercial Distribution Discontinuation: 2020-01-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SP
• Version Model Number: B3158-1
• Catalog Number: B3158-1
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20630140008501 [Primary]

FDA Product Code

• GIF: DILUENT, BLOOD CELL

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: 2020-01-03
• Device Publish Date: 2018-12-27

On-Brand Devices [SP]

• 00630140058861: SP Brand Immu-Sal Saline; For Use in Immunohematological Procedures; For In Vitro Diagnostic Use
• 20630140008518: Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro
• 20630140008501: Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro
• 50630140008496: Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro
• 50630140057500: Surgical Blade; Stainless Steel; Size 21
• 50630140057494: Surgical Blade; Stainless Steel; Size 20
• 50630140057487: Surgical Blade; Stainless Steel; Size 15
• 50630140057470: Surgical Blade; Stainless Steel; Size 12
• 50630140057463: Surgical Blade; Stainless Steel; Size 11
• 50630140057456: Surgical Blade; Stainless Steel; Size 10