McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 00612479199576
• Version / Model: 37-6270
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-12
• Public Version: 4
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: b401325e-db28-4b13-8c12-74a6b2c50a0b
• Distribution End Date: 2024-02-01

Device Description

250 mL USP Sterile Saline, Screw Top Container

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63285	Multi-purpose therapeutic saline solution	A water-based salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple patient applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care in the home. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00612479168596	GS1	Case	24	Not in Commercial Distribution	2024-02-01
Primary	00612479199576	GS1

Premarket Submissions

Submission Number	Supplement Number
K083042	000