XSTAT P30 FIN-0017-21

GUDID 00851587006226

Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaque marker.

Revmedx, Inc.

Radiopaque woven surgical sponge

• Primary Device ID: 00851587006226
• NIH Device Record Key: 7f9d43a2-36b6-4352-965c-6ae84e695a29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XSTAT P30
• Version Model Number: FIN-0017-21
• Catalog Number: FIN-0017-21
• Company DUNS: 961523441
• Company Name: Revmedx, 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: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com

Device Dimensions

• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851587006226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210676

FDA Product Code

• PGZ: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-27
• Device Publish Date: 2023-01-17

Devices Manufactured by Revmedx, Inc.

• 00851587006080 - AirWrap: 2026-02-27 Pressure bandage
• 00851587006226 - XSTAT P30: 2026-02-27Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaque marker.
• 00851587006226 - XSTAT P30: 2026-02-27 Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaqu
• 00851587006066 - XSTAT: 2019-04-05 A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked wi
• 00851587006042 - XSTAT: 2018-07-06 A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked wit
• 10851587006056 - XSTAT: 2018-07-06 A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked wit