PCD Arm 20303

GUDID 00817369022488

PCD Left Arm

NORMATEC INDUSTRIES LP

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 00817369022488
• NIH Device Record Key: c6160392-5f2f-4cdd-8d56-2a4c3f61ffc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCD Arm
• Version Model Number: PCD Left Arm
• Catalog Number: 20303
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369022488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161346

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2016-11-07

On-Brand Devices [PCD Arm]

• 00817369022488: PCD Left Arm
• 00817369022471: PCD Right Arm