NA

Basic Information

• Brand Name: NA
• Primary DI: 04719873695669
• Version / Model: S1004-6030
• Company Name: CARILEX MEDICAL, INC.
• Labeler DUNS: 658863238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-16
• Public Version: 2
• Public Version Date: 2022-12-16
• Public Version Status: Update
• Public Device Record Key: 7c39d5bc-9c0c-4a32-a28f-c3ceee606e02

Device Description

Canister for VT• One - 150ml luer lock

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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	Bottle, Collection, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47408	Negative-pressure wound therapy system pump, electric	A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04719873695676	GS1		5	Not in Commercial Distribution	2022-12-16
Primary	04719873695669	GS1
Package	04719873695683	GS1		8	Not in Commercial Distribution	2022-12-16
Package	14719873695666	GS1		5	In Commercial Distribution
Package	24719873695663	GS1		10	In Commercial Distribution