PH Band PHB-001U

GUDID 00860006401702

PH Band

Medical Ingenuities, LLC

Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device

• Primary Device ID: 00860006401702
• NIH Device Record Key: 1623304b-b5d6-40e8-972e-e8cfce345ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PH Band
• Version Model Number: 41111-01
• Catalog Number: PHB-001U
• Company DUNS: 039411940
• Company Name: Medical Ingenuities, LLC
• 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: true
• 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: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com
• Phone: 224-661-0808
• Email: support@medicalingenuities.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006401702 [Primary]
GS1	10860006401709 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201695

FDA Product Code

• DXC: Clamp, Vascular

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: 2021-04-30
• Device Publish Date: 2021-04-22