Suction Unit

GUDID 00616784082011

DYNAREX CORPORATION

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• Primary Device ID: 00616784082011
• NIH Device Record Key: f32e2f1d-f18c-4655-ae60-6e74c871d8fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suction Unit
• Version Model Number: 10820
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784082011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042349

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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: 2020-05-06
• Device Publish Date: 2019-11-06

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