Pulse Power Kit 40030

GUDID 00817369020859

Pulse Power Kit - US

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system

• Primary Device ID: 00817369020859
• NIH Device Record Key: 8ea00b2b-2e23-4d7e-bd06-2c0622f51a8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Power Kit
• Version Model Number: Pulse Power Kit - US
• Catalog Number: 40030
• 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	00817369020859 [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

Devices Manufactured by NORMATEC INDUSTRIES LP

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• 00810050281720 - NormaTec: 2023-06-26
• 00810050281768 - NormaTec: 2023-06-26
• 00810050281782 - NormaTec: 2023-06-26
• 00810050281805 - NormaTec: 2023-06-26
• 00810050281829 - NormaTec: 2023-06-26
• 00810050281836 - NormaTec: 2023-06-26
• 00810050281881 - NormaTec: 2023-06-26