Areza Medical SA42520
GUDID 00850021481841
The dressing is made from natural alginate fibers and silver. Silver particle in the dressing can restrain growth of biologic pathogens in the wound and help reduce further wound infection. The dressing has been tested in vitro and found to be effective against several important biologic pathogens affecting wounds. It is designed to be highly absorbent. The dressing, while absorbing wound drainage (exudates), forms a gel-like covering over the wound, which provides an ideal moist environment. Moist wound healing is known to expedite wound healing. The gel-like surface also prevents the dressing from adhering to the wound, making removal painless.
ADVANCED MEDICAL ASSOCIATES, LLC
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial| Primary Device ID | 00850021481841 |
| NIH Device Record Key | bca306f7-e15c-4456-83c6-fbbdfd3ca64d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Areza Medical |
| Version Model Number | SA42520 |
| Catalog Number | SA42520 |
| Company DUNS | 047724226 |
| Company Name | ADVANCED MEDICAL ASSOCIATES, LLC |
| Device Count | 20 |
| 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 | 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 | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com | |
| Phone | (214) 356-8716 |
| info@arezamedical.com |
Device Dimensions
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
| Length | 4.25 Inch |
| Width | 4.25 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850021481148 [Unit of Use] |
| GS1 | 00850021481773 [Primary] |
| GS1 | 00850021481841 [Package] Contains: 00850021481773 Package: Inner case [20 Units] In Commercial Distribution |
| GS1 | 00850021481889 [Package] Contains: 00850021481773 Package: Case [40 Units] In Commercial Distribution |
FDA Product Code
| FRO | Dressing, Wound, Drug |
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 | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
On-Brand Devices [Areza Medical]
| 00850021481148 | Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed |
| 00850021481070 | Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (2 Roll)is composed of a soft, p |
| 00850021481322 | Foam dressings are sheets of foamed polymer solutions (most commonly polyurethane) with small, o |
| 00850021481308 | Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self a |
| 00850021481261 | Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel s |
| 00850021481186 | Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, with a |
| 00850021481162 | Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate is made of natu |
| 00850021481049 | Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a superior ab |
| 00850021481285 | Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a centr |
| 00850021481247 | Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane (PU) film, with a |
| 00850021481094 | Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (12 Roll) is composed of a soft, |
| 00850021481087 | Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (3 Roll) is composed of a soft, |
| 00850021481056 | Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wou |
| 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, |
| 00850021481346 | Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic |
| 00850021481025 | Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 7" x 6.8" |
| 00850021481360 | Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 9.2" x 9.2" |
| 00850021481537 | Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border and Flaps 7.2" x 7.8" Box of |
| 00850021481599 | Areza Carboxymethyl Cellulose(CMC) Gelling Fiber 4.25” x 4.25” (10.75 x 10.75 cm) 10 pcs |
| 00810147400171 | AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle |
| 00810147400157 | AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle |
| 00810147400195 | AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle |
| 00810147401123 | Transparent Adhesive Film Dressing - 4" x 4" 3/4" (20) consists of a thin polyurethane (PU) film |
| 00810147401314 | Transparent Adhesive Film Dressing - 12" x 8" (10) consists of a thin polyurethane (PU) film, wi |
| 00810147401284 | Transparent Adhesive Film Dressing - 12" x 8" (5) consists of a thin polyurethane (PU) film, wit |
| 00810147401246 | TF8620 |
| 00810147401215 | Transparent Adhesive Film Dressing - 8" x 6" (10) consists of a thin polyurethane (PU) film, wit |
| 00810147401178 | Transparent Adhesive Film Dressing - 4" x 4" 3/4" (100) consists of a thin polyurethane (PU) fil |
| 00810147401147 | Transparent Adhesive Film Dressing - 4" x 4" 3/4" (50) consists of a thin polyurethane (PU) film |
| 00850021481872 | The dressing is made from natural alginate fibers and silver. Silver particle in the dressing c |
| 00850021481841 | The dressing is made from natural alginate fibers and silver. Silver particle in the dressing c |
| 00850021481827 | Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic |
| 00850021481865 | Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic |
| 00810147400850 | Areza Island Wound Dressing (Bordered Gauze) is a sterile and self-adhesive dressing. The centra |
| 00810147400836 | Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self-a |
| 00850021481957 | Areza Sacral Ultra-Absorbent Foam with Adhesive Border and Flaps consists of a fenestrated silic |
| 00810147400270 | COPOV10 |
| 00810147400232 | COPOVV10 |
| 00850021481766 | Areza Medical's Retention Tape is ideal for securing medical devices, dressings, and tubes in pl |
Trademark Results [Areza Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AREZA MEDICAL 87720350 not registered Live/Pending |
Advanced Medical Associates LLC 2017-12-14 |
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