FDA.reportPublic FDA data

Solventum™ Adaptic™

Primary DI
00197998296642
Brand
Solventum™ Adaptic™
Company
Solventum Germany GmbH
Model
2019
Catalog number
2019
Device description
Solventum™ Adaptic™ Non-adhering Dressing, 2019, 5 in x 9 in (12.7 cm x 22.9 cm), 12/CAR, 6 CAR/CS, 72/CS
Published
2026-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998296666PackageGS172In Commercial Distribution
00197998296642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998296666001979982966661979982966660197998296666
00197998296642001979982966421979982966420197998296642

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The product label and the related stability data indicate that the product should be stored at 40°C (104°F).

Contacts#

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

Regulatory Flags#

DUNS number
315518329
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00197998296499Solventum™ Adaptic™201820182026-04-10
00197998296680Solventum™ Adaptic™201520152026-04-10
00197998296727Solventum™ Adaptic™201420142026-04-10
00197998296772Solventum™ Adaptic™201320132026-04-10
00197998296819Solventum™ Adaptic™201220122026-04-10
00197998118654Solventum™ Promogran Prisma™MA032MA0322026-04-10
00197998175190Solventum™ Promogran Prisma™PS2123PS21232026-04-10
00197998291128Solventum™ Promogran Prisma™MA123MA1232026-04-10
00197998291166Solventum™ Promogran Prisma™MA028MA0282026-04-10
00197998291203Solventum™ Promogran Prisma™PS2028PS20282026-04-10
00197998018930Solventum™36716367162026-05-08
00197998018947Solventum™36717367172026-05-08
00197998022579Solventum™76310763102026-05-08
00197998024252Solventum™69940699402026-05-08
00197998024269Solventum™41928419282026-05-08
00197998024276Solventum™41925419252026-05-08
00197998024290Solventum™41926419262026-05-08
00197998024306Solventum™69952699522026-05-08
00197998024313Solventum™69951699512026-05-08
00197998024320Solventum™69950699502026-05-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
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06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
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06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29