Procellera Single Layer VSR-1212

GUDID 00810198030358

Procellera Single Layer Rx 12" x 12"

Vomaris Wound Care, Inc.

Portable pneumatic high-frequency ventilator

• Primary Device ID: 00810198030358
• NIH Device Record Key: 76f21b58-87e0-47b7-a8e2-266b7e023a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera Single Layer
• Version Model Number: 12" x 12"
• Catalog Number: VSR-1212
• Company DUNS: 080126901
• Company Name: Vomaris Wound Care, 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: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810198030310 [Primary]
GS1	00810198030358 [Package]; Contains: 00810198030310; Package: Box [1 Units]; In Commercial Distribution
GS1	00810198030365 [Package]; Contains: 00810198030310; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160783

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [Procellera Single Layer]

• 00894318002647: Procellera Single Layer Rx, 1" x 1"
• 00894318002630: Procellera Single Layer Rx, 1.5" x 8"
• 00894318002623: Procellera Single Layer Rx, 1.5" x 10"
• 00894318002616: Procellera Single Layer Rx, 2" x 2"
• 00894318002609: Procellera Single Layer Rx, 2" x 5"
• 00894318002593: Procellera Single Layer Rx, 3" x 3"
• 00894318002586: Procellera Single Layer Rx, 4" x 4"
• 00894318002579: Procellera Single Layer Rx, 5" x 5"
• 00810198030389: Procellera Single Layer OTC, 4"x 4"
• 00810198030372: Procellera Single Layer OTC, 2"x2"
• 00810198030358: Procellera Single Layer Rx 12" x 12"
• 00810198030327: Procellera Single Layer Rx 8" x 8"
• 00810198030013: Procellera Single Layer Rx, 4" x 8"