Areza Medical 44220

GUDID 00850021481056

Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wound contact layer, an absorbent polyurethane (PU) foam pad layer, and a vapor permeable and waterproof polyurethane film backing. The triple-layer construction facilitates dynamic fluid management to provide optimal moist wound environment; and may help reduce the risk of maceration. The absorbent pad layer provides superior absorption locking away exudates.

ADVANCED MEDICAL ASSOCIATES, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial

• Primary Device ID: 00850021481056
• NIH Device Record Key: f41ad0fe-bf03-41e5-93d9-c665c74d5a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areza Medical
• Version Model Number: 44220
• Catalog Number: 44220
• Company DUNS: 047724226
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Device Count: 5
• DM Exempt: false
• 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com
• Phone: 877-931-1387
• Email: info@arezamedical.com

Device Dimensions

• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter
• Circumference: 23.88 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry, cool environment. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021481056 [Primary]
GS1	00850021481223 [Unit of Use]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2020-11-04
• Device Publish Date: 2020-10-27

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• 00850021481032: Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fen
• 00850021481063: Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (1 Roll) is composed of a soft,
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• 00810147400195: AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle