Jet-Vac Procedure Trays

Basic Information

• Brand Name: Jet-Vac Procedure Trays
• Primary DI: 00813623011366
• Version / Model: M7853
• Catalog Number: M7853
• Company Name: PFM MEDICAL INCORPORATED
• Labeler DUNS: 097736867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-02
• Public Version: 3
• Public Version Date: 2019-09-06
• Public Version Status: Update
• Public Device Record Key: 3fb48eec-9d70-4f26-a918-56bfdf724cce

Device Description

5F x 7cm Jet-Vac® Procedure Trays

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: 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
GCB	Needle, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813623011363	GS1		5	In Commercial Distribution
Primary	00813623011366	GS1

Customer Contacts

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