Sensica UO 1-005-0040

GUDID 10854003008009

Automated urine meter system for continuous monitoring of urine output

ADAPTEC MEDICAL DEVICES LLC

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• Primary Device ID: 10854003008009
• NIH Device Record Key: 9d02931c-a90e-4533-a421-b7dfd9726852
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensica UO
• Version Model Number: SCCS-1001
• Catalog Number: 1-005-0040
• Company DUNS: 090250920
• Company Name: ADAPTEC MEDICAL DEVICES LLC
• 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: 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	00854003008002 [Primary]
GS1	10854003008009 [Package]; Contains: 00854003008002; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• EXS: Urinometer, Electrical

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: 2018-11-30
• Device Publish Date: 2018-10-30

Devices Manufactured by ADAPTEC MEDICAL DEVICES LLC

• 00854003008019 - Sensica: 2019-09-13
• 10854003008009 - Sensica UO: 2018-11-30Automated urine meter system for continuous monitoring of urine output
• 10854003008009 - Sensica UO: 2018-11-30 Automated urine meter system for continuous monitoring of urine output