Jac-cell USA Inc.

GUDID B461JAU97971

SAF-T-VAC Smoke and Fluid Evacuator

JAC CELL USA INC

Surgical plume evacuation system tube

• Primary Device ID: B461JAU97971
• NIH Device Record Key: 01ead1c8-53d6-4681-9c66-74a5c2de733b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jac-cell USA Inc.
• Version Model Number: JAU-9797
• Company DUNS: 015023538
• Company Name: JAC CELL USA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B461JAU97971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170582

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-28

On-Brand Devices [Jac-cell USA Inc.]

• B461JAU97971: SAF-T-VAC Smoke and Fluid Evacuator
• B461JAU3092R0: Reusable Push Button Pencil With Stamping Blade ,3M Cable
• B461JAU15201: Disposal standard blade electrode
• B461JAU142213: PENCIL, Push Button w/SS Blade&Holster Disposable
• B461JAU117013: INFILTRATION TUBING FOR PERISTALTIC PUMP WITH 2 SPIKES
• B461JAU11681: Infiltration tubing for peristaltic pumps