Soma Safe Enclosure

GUDID 00861402000421

AC powered hospital bed with affixed frame for structural support of a canopy to prevent patient from exiting bed unassisted

VIVAX MEDICAL CORPORATION

Basic electric hospital bed

• Primary Device ID: 00861402000421
• NIH Device Record Key: e71e1d65-bdde-4a0b-a471-d21eb58ac65a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soma Safe Enclosure
• Version Model Number: SSE 300e
• Company DUNS: 154815062
• Company Name: VIVAX MEDICAL CORPORATION
• 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: true
• 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

Customer Support Contacts

• Phone: +1(203)729-0514
• Email: info@vivaxmedical.com

Device Dimensions

• Width: 39 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861402000421 [Primary]

FDA Product Code

• FNM: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

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: 2020-03-19
• Device Publish Date: 2020-03-11

On-Brand Devices [Soma Safe Enclosure]

• 00861402000414: Frame for structural support of a canopy to prevent patient from exiting bed unassisted
• 00861402000407: Canopy afixed to frame encompassing a hospital bed preventing the patient from exiting without a
• 00861402000445: AC powered low hosptial bed with affixed frame for structural support of a canopy to prevent pat
• 00861402000438: Manual hospital bed with affixed frame for structural support of a canopy to prevent patient fro
• 00861402000421: AC powered hospital bed with affixed frame for structural support of a canopy to prevent patient
• 00861402000483: Frame for structural support of a canopy to prevent patient from exiting bed unassisted
• 00861402000476: Frame for structural support of a canopy to prevent patient from exiting bed unassisted
• 00861402000469: Frame for structural support of a canopy to prevent patient from exiting bed unassisted
• 00861402000452: Frame for structural support of a canopy to prevent patient from exiting bed unassisted