Vive Health

GUDID 10818323027058

SOFT SPLINT MEDIUM

VIVE HEALTH LLC

Cast shoe, reusable Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis

• Primary Device ID: 10818323027058
• NIH Device Record Key: 5877c22b-0e8b-41b6-94ea-543195080018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Health
• Version Model Number: SUP1037M
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818323027051 [Primary]
GS1	10818323027058 [Package]; Contains: 00818323027051; Package: CASE [24 Units]; In Commercial Distribution

FDA Product Code

• IPG: Shoe, Cast

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: 2019-03-19
• Device Publish Date: 2019-03-11

On-Brand Devices [Vive Health]

• 10818323027126: Posture Corrector Medium
• 10818323027065: SOFT SPLINT SMALL
• 10818323027058: SOFT SPLINT MEDIUM
• 10818323027041: SOFT SPLINT LARGE
• 10818323020127: Syphgmomanometer (Black)
• 10810113572618: Car Assist Handle (2PK)
• 10810041988086: Car Assist Handle
• 10810041986181: Wrist Blood Pressure Monitor (Model BT-V)
• 10810113570355: Sports Compression Socks (Black) Large
• 10810113570348: Sports Compression Socks (Black) Medium
• 10810113570331: Sports Compression Socks (Black) Small
• 10818323029779: Multi- Purpose Leg Lifter
• 10810113572823: Bariatric Shower Chair
• 10810113572762: Alternating Pressure Pad (Lite)
• 10810113571888: Portable Stand Assist
• 10810041989205: Spill Proof Scoop Plate (2PK)