Simpulse VariCare

Basic Information

• Brand Name: Simpulse VariCare
• Primary DI: 00801741065316
• Version / Model: 0067030
• Catalog Number: 0067030
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-05
• Public Version: 3
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 9ef7ce7a-b8c0-471a-9c91-51e40155799e

Device Description

Simpulse VariCare Wound Management Kit with VariCare Retractable Small (1.25"diameter) Splash Shield Wound Tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65140	Surgical irrigation/aspiration pump, single-use	An electrically-powered device intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, in conjunction with a patient contact device (not included), usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include noninvasive accessories (e.g., collection container, tubing); it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801741065310	GS1	CA	2	In Commercial Distribution
Package	10801741065313	GS1	BX	5	In Commercial Distribution
Primary	00801741065316	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 65 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius