SP

Basic Information

• Brand Name: SP
• Primary DI: 20630140008501
• Version / Model: B3158-1
• Catalog Number: B3158-1
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-27
• Public Version: 3
• Public Version Date: 2020-01-03
• Public Version Status: Update
• Public Device Record Key: e160cc87-fe45-4c65-a4f0-7453ec2f8ba2
• Distribution End Date: 2020-01-03

Device Description

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

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
GIF	DILUENT, BLOOD CELL	Hematology	864.8200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59063	Red cell antibody diluent IVD, reagent	A substance or reactant that is an antibody-free solution intended to be used as a diluent in the immunohaematological testing of a clinical specimen for the semi-quantitative determination of a red blood cell antibody, using a serial dilution or titration technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20630140008501	GS1

Storage Conditions

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