FDA.reportPublic FDA data

XeroBurn Burn Dressing Face Mask- Sterile

Primary DI
00840117333079
Brand
XeroBurn Burn Dressing Face Mask- Sterile
Company
DYNAREX CORPORATION
Model
1371
Device description
12" x 16"
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117333062PackageGS12In Commercial Distribution
00840117333079PackageGS16In Commercial Distribution
00840117333277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117333062008401173330628401173330620840117333062
00840117333079008401173330798401173330790840117333079
00840117333277008401173332778401173332770840117333277

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer burn dressing, gel-coatedA sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 10x10 cm to 60x40 cm) and may be body contoured; it is also available in prefabricated shapes (e.g., face mask). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117307605Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3"106852021-04-22
00840117307629Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3"106862021-04-22
00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
00616784065311Ever-Soft Foam Cushion 20" x 16" x 3"106532021-04-22
00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
00840117307568Ever-Soft Coccyx Foam Cushion 18" x 16" x 3"106552021-04-22
00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

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