SOMAVAC 100 Sustained Vacuum System 10011

GUDID 00850004219027

Portable, battery powered vacuum source with waste containers and accessories.

SOMAVAC MEDICAL SOLUTIONS, INC.

Closed-wound drainage suction pump

• Primary Device ID: 00850004219027
• NIH Device Record Key: 6039a784-bcd1-49b0-b401-2a8b9ae751e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMAVAC 100 Sustained Vacuum System
• Version Model Number: 10011
• Catalog Number: 10011
• Company DUNS: 080446796
• Company Name: SOMAVAC MEDICAL SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00850004219027 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

Devices Manufactured by SOMAVAC MEDICAL SOLUTIONS, INC.

• 10850004219079 - SOMAVAC Drain Connector - Dual Input: 2020-12-28 Somavac Drain Connector with two inputs and a single output.
• 00850004219096 - SOMAVAC Drain Connector - Dual Output: 2020-12-28 Sterile Drain Connector with a single input and two outputs.
• 00850004219041 - SOMAVAC Waste Collection Unit: 2020-05-06 Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
• 00850004219034 - SOMAVAC Drain Connector: 2020-01-01 Filter and check valve; one end barb, one end Luer.
• 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: 2019-09-09Portable, battery powered vacuum source with waste containers and accessories.
• 00850004219027 - SOMAVAC 100 Sustained Vacuum System: 2019-09-09 Portable, battery powered vacuum source with waste containers and accessories.