swiftPro Battery Power System SWF-BPS01

GUDID 05060652910152

swiftPro Battery Power System

EMBLATION LIMITED

Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger

• Primary Device ID: 05060652910152
• NIH Device Record Key: 076d2c54-c415-46a7-aeaf-751b65313d21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: swiftPro Battery Power System
• Version Model Number: SWF-BPS01
• Catalog Number: SWF-BPS01
• Company DUNS: 211334261
• Company Name: EMBLATION LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060652910152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240518

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

Devices Manufactured by EMBLATION LIMITED

• 05060652910138 - swiftPro Battery Pack: 2024-07-04 The battery pack for the swiftPro Hand-held Microwave Generator
• 05060652910145 - swiftPro Charging Dock: 2024-07-04 The swiftPro Charging dock
• 05060652910152 - swiftPro Battery Power System: 2024-07-04swiftPro Battery Power System
• 05060652910152 - swiftPro Battery Power System: 2024-07-04 swiftPro Battery Power System
• 05060652910053 - swiftPro System: 2023-12-12 swiftPro System
• 05060652910060 - swiftPro Hand-Held Microwave Generator: 2023-12-12 The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft t
• 05060652910077 - swiftPro DC power adaptor: 2023-12-12 The swiftPro DC power adaptor is used to power the swiftPro hand-held generator
• 05060652910084 - swiftPro Cradle: 2023-12-12 The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
• 05060652910091 - swiftPro URT Applicator Tip: 2023-12-12 The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp