Splash Medical Devices

Basic Information

• Brand Name: Splash Medical Devices
• Primary DI: 10809160226100
• Version / Model: 71562
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-05
• Public Version: 1
• Public Version Date: 2019-03-08
• Public Version Status: New
• Public Device Record Key: 6b9a8fbc-4d54-4c4f-959a-0f12a2e1ee98

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160226107	GS1		50	In Commercial Distribution
Primary	10809160226100	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE AT ROOM TEMPERATURE
• Type: Special Storage Condition, Specify