FDA.reportPublic FDA data

Solventum™ Kerramax Care™

Primary DI
00197998276262
Brand
Solventum™ Kerramax Care™
Company
Solventum US LLC
Model
PRD500-240-B30
Catalog number
PRD500-240-B30
Device description
Solventum™ Kerramax Care™ Super-absorbent Dressing, PRD500-240-B30, 8 inx 9 in (20 cm x 22 cm), 30/CAR, 12 CAR/CS, 360/CS
Published
2026-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998276279PackageGS112In Commercial Distribution
00197998276262PrimaryGS10
00197998276095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998276279001979982762791979982762790197998276279
00197998276262001979982762621979982762620197998276262
00197998276095001979982760951979982760950197998276095

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
30
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998382819Solventum™ Veraflo™ Cleanse Choice™ULTVCC05MDULTVCC05MD2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™ULTVCC05LGULTVCC05LG2026-05-28
00197998470417Solventum™ Bair Hugger™90135901352026-05-15
00197998054457Solventum™ Tegaderm™90112901122026-04-10
00197998054495Solventum™ Tegaderm™90114901142026-04-10
00197998054532Solventum™ Tegaderm™90110901102026-04-10
00197998054570Solventum™ Tegaderm™90120901202026-04-10
00197998470431Solventum™ Bair Hugger™90108901082026-04-29
00197998470455Solventum™ Bair Hugger™90107901072026-04-29
087114280529303M™ Scotchcast™82199821992026-04-18
087114280529543M™ Scotchcast™82299822992026-04-18
087114280529923M™ Scotchcast™82200822002026-04-18
087114280530363M™ Scotchcast™82201822012026-04-18
087114280530503M™ Scotchcast™82202822022026-04-18
040467194325613M™ Scotchcast™82002820022026-04-18
040467194325783M™ Scotchcast™82002A82002A2026-04-18
040467194326223M™ Scotchcast™82002V82002V2026-04-18
040467194326463M™ Scotchcast™82002W82002W2026-04-18
040467194326913M™ Scotchcast™82002B82002B2026-04-18
040467194327143M™ Scotchcast™82002G82002G2026-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22