SP

Basic Information

• Brand Name: SP
• Primary DI: 00630140058861
• Version / Model: B5052-25
• Catalog Number: B5052-25
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-27
• Public Version: 2
• Public Version Date: 2020-06-29
• Public Version Status: Update
• Public Device Record Key: 7af3f1c5-f9a6-45b4-9b89-75144a822cd7

Device Description

SP Brand Immu-Sal Saline; For Use in Immunohematological Procedures; For In Vitro Diagnostic Use; For Laboratory Use Only; Not Intended For Internal Use; Not for Infusion, Injection, Irrigation, or Ingestion; 2.5 gal

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• 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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43674	Isotonic saline reagent IVD	An unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630140058861	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius