Meridian Medical

GUDID 30815067043843

Full Leg Single Chamber Sleeve, Medium

COMPASS HEALTH BRANDS CORP.

Single-chamber venous compression system garment, reusable

• Primary Device ID: 30815067043843
• NIH Device Record Key: c4135d1a-259a-4a2d-b6b4-f30a075b3883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian Medical
• Version Model Number: SLV-FLM
• Company DUNS: 827221698
• Company Name: COMPASS HEALTH BRANDS CORP.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 440-572-1962
• Email: CustomerService@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815067043842 [Primary]
GS1	30815067043843 [Package]; Contains: 00815067043842; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974393

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2019-04-25
• Device Publish Date: 2019-04-17

On-Brand Devices [Meridian Medical]

• 00815067043385: 5'' APM SYSTEM-8LPM PUMP
• 00815067043361: 42" APM Mattress
• 00815067042869: 4840-42
• 00815067042814: MER-4500
• 30815067040156: 8" APM SYSTEM
• 00815067040148: 4800 84" SYSTEM
• 00815067040131: 8" HOMECARE APM
• 00815067040100: 8'' APM WITH FOAM TUB
• 30815067040095: 8'' APM MATTRESS-NO FOAM
• 30815067040088: 84 INCH - 4802 DC U/C EXCEL SY
• 00815067040070: 48'' APM BARIATRIC SYSTEM
• 30815067040064: 8'' APM MATTRESS
• 00815067040018: 8" HOMECARE MATTRESS (Master Carton Only)
• 30815067043874: Full Arm Single Chamber Sleeve, Short
• 30815067043867: Full Arm Single Chamber Sleeve, Medium
• 30815067043850: Full Leg Single Chamber Sleeve, Long
• 30815067043843: Full Leg Single Chamber Sleeve, Medium
• 30815067043836: Full Leg Single Chamber Sleeve, Short
• 30815067043829: Half Leg Single Chamber Sleeve
• 00092237616239: ARUBA-200 CONVOLUTED FOAM MATTRESS
• 00815067043521: Meridian Medical APP System - adjustable pump and single layer pad
• 00815067044061: ARUBA-42 BARIATRIC GROUP11 FOAM MATTRESS
• 00092237616246: CONTOUR FOAM CORE MATTRESS, GROUP 1, 36"x 84", 350 LB CAP