New Balance

GUDID 20888625001619

Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe

RENFRO CORPORATION

Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable Compression/pressure sock/stocking, reusable

• Primary Device ID: 20888625001619
• NIH Device Record Key: 99f942e1-039b-4f81-9fe3-a5442f76dfc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: New Balance
• Version Model Number: N915 Black Large
• Company DUNS: 003219318
• Company Name: RENFRO CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com
• Phone: 865-655-8134
• Email: callcenter@renfro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888625001615 [Primary]
GS1	20888625001619 [Package]; Contains: 00888625001615; Package: Baler Bag [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123398

FDA Product Code

• DWL: Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-11-08

On-Brand Devices [New Balance]

• 20888625011403: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
• 20888625011397: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
• 20888625001633: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
• 20888625001626: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
• 20888625001619: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
• 20888625001602: Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe