ABS Nozzle ABS-1002

GUDID 00869284000232

NIMBIC SYSTEMS, INC.

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• Primary Device ID: 00869284000232
• NIH Device Record Key: d0166138-80be-488c-93a2-725a49db9182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABS Nozzle
• Version Model Number: Model 1002
• Catalog Number: ABS-1002
• 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: 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

Customer Support Contacts

• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com
• Phone: 281-565-5750
• Email: info@nimbicsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869284000201 [Primary]
GS1	00869284000232 [Package]; Contains: 00869284000201; Package: [5 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-20

Devices Manufactured by NIMBIC SYSTEMS, INC.

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