SOMAVAC Waste Collection Unit 20021

GUDID 00850004219041

Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.

SOMAVAC MEDICAL SOLUTIONS, INC.

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• Primary Device ID: 00850004219041
• NIH Device Record Key: 62e83fe4-2dda-4b02-b268-6b08ba2f76db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMAVAC Waste Collection Unit
• Version Model Number: 20021
• Catalog Number: 20021
• Company DUNS: 080446796
• Company Name: SOMAVAC MEDICAL SOLUTIONS, 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: true
• 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	00850004219041 [Primary]
GS1	10850004219048 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	10850004219086 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180606

FDA Product Code

• GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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: 2019-08-23

Devices Manufactured by SOMAVAC MEDICAL SOLUTIONS, INC.

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• 00850004219041 - SOMAVAC Waste Collection Unit: 2020-05-06Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
• 00850004219041 - SOMAVAC Waste Collection Unit: 2020-05-06 Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
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• 00850004219058 - SOMAVAC Belt: 2019-12-11 Belt for SOMAVAC Sustained Vacuum System; 25-50in.
• 10850004219062 - SOMAVAC Belt Extender: 2019-12-11 Extender for SOMAVAC Belt, 80 in.
• 00850004219010 - SOMAVAC 100 Vacuum Source: 2019-09-09 Portable battery powered vacuum source at 100mmHg
• 00850004219027 - SOMAVAC 100 Sustained Vacuum System: 2019-09-09 Portable, battery powered vacuum source with waste containers and accessories.