Power Supply 30112

GUDID 00817369020606

Power Supply - Pulse S. African Adapter

NORMATEC INDUSTRIES LP

Intermittent venous compression system

• Primary Device ID: 00817369020606
• NIH Device Record Key: 5f51f3b6-7550-404c-ae56-f7c44894ff60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Supply
• Version Model Number: Power Supply - Pulse S. African Adapter
• Catalog Number: 30112
• Company DUNS: 111448069
• Company Name: NORMATEC INDUSTRIES LP
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369020606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160608

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Power Supply]

• 00817369020606: Power Supply - Pulse S. African Adapter
• 00817369020590: Power Supply - Pulse US Adapter
• 00817369020583: Power Supply - Pulse UK Adapter
• 00817369020576: Power Supply - Pulse EU Adapter
• 00817369020569: Power Supply - Pulse AU Adapter
• 00817369020552: Power Supply - Pulse
• 00817369020545: Power Supply - 12 V DC 30 Watt
• 00817369020538: Power Supply - 12 V DC 60 Watt