Earmates

GUDID 10709078008563

Earmates, Charcoal (Pair)

WESTMED, INC.

Patient tube cushion

• Primary Device ID: 10709078008563
• NIH Device Record Key: b9fa4bad-8798-47a7-a087-2602e4a58448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earmates
• Version Model Number: 0440
• Company DUNS: 092673953
• Company Name: WESTMED, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078008566 [Primary]
GS1	10709078008563 [Package]; Contains: 00709078008566; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• NVO: Spacer, Direct Patient Interface

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-06-02

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