ABS Blower Unit ABS-2002

GUDID 00869284000249

NIMBIC SYSTEMS, INC.

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• Primary Device ID: 00869284000249
• NIH Device Record Key: dad9b67b-6ec1-41d4-bcaa-0323cc57ac30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABS Blower Unit
• Version Model Number: Model 2002
• Catalog Number: ABS-2002
• Company DUNS: 868730834
• Company Name: NIMBIC SYSTEMS, INC.
• 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869284000249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123006

FDA Product Code

• ORC: Air Filter Portable Apparatus

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: 2018-12-17
• Device Publish Date: 2018-11-15

Devices Manufactured by NIMBIC SYSTEMS, INC.

• 00869284000249 - ABS Blower Unit: 2018-12-17
• 00869284000249 - ABS Blower Unit: 2018-12-17
• 00869284000232 - ABS Nozzle: 2018-07-06
• 00869284000225 - ABS Velcro Pad: 2018-07-06 Box of 10 Velcro Pads