Areza Medical FADWR6.5

GUDID 00850021481285

Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a central polyurethane (PU) foam pad with a size of 4.1” x 4.1” and 5 mm thickness. Foam pad is to lay on exuding wounds and is non-adhesive as long as it is used on actively exuding wounds. 2- a very thin PU backing layer which is soft, white in color, breathable, and reinforced with Spunlace, nonwoven fabric mesh. Note: this layer provides water resistance, but it is not waterproof. Meaning liquid may cross from the outer surface to the inside with some delay (normally about 10-20 mins or longer). Unless the foam is soaked, exudate does not cross from the inner surface to outer surface. This dressing is not suitable for showering or swimming. 3- an adhesive layer composed of medical grade Henkel glue that is adhered onto the second layer, the Spunlace, nonwoven fabric mesh.

ADVANCED MEDICAL ASSOCIATES, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial
Primary Device ID00850021481285
NIH Device Record Keyde071d35-f1c2-43ab-8206-6ebf6290fdec
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreza Medical
Version Model NumberFADWR6.5
Catalog NumberFADWR6.5
Company DUNS047724226
Company NameADVANCED MEDICAL ASSOCIATES, LLC
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM
Phone877-931-1387
EmailINFO@AREZAMEDICAL.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry, cool place. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850021481278 [Primary]
GS100850021481285 [Unit of Use]

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-04
Device Publish Date2020-10-27

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00850021481247Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane (PU) film, with a
00850021481094Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (12 Roll) is composed of a soft,
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00850021481032Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fen
00850021481063Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (1 Roll) is composed of a soft,
00850021481346Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic
00850021481025Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 7" x 6.8"
00850021481360Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 9.2" x 9.2"
00850021481537Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border and Flaps 7.2" x 7.8" Box of
00850021481599Areza Carboxymethyl Cellulose(CMC) Gelling Fiber 4.25” x 4.25” (10.75 x 10.75 cm) 10 pcs
00810147400171AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle
00810147400157AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle
00810147400195AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle

Trademark Results [Areza Medical]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AREZA MEDICAL
AREZA MEDICAL
87720350 not registered Live/Pending
Advanced Medical Associates LLC
2017-12-14
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