IMAK Ergo

GUDID 00649833301115

HappiNeck

BROWNMED, INC.

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• Primary Device ID: 00649833301115
• NIH Device Record Key: 42d28278-3c62-43d9-b5a6-1fce4d8fc5e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAK Ergo
• Version Model Number: A30111
• Company DUNS: 091999771
• Company Name: BROWNMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00649833301115 [Primary]

FDA Product Code

• IQK: Orthosis, Cervical

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: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [IMAK Ergo]

• 00649833301122: HappiNeck
• 00649833301115: HappiNeck