FDA.reportPublic FDA data

Solventum US LLC

Primary DI
00197998028847
Brand
Solventum US LLC
Company
KCI USA, INC.
Model
STPALPEE
Catalog number
STPALPEE
Device description
Solventum™ Snap™ Plus Therapy Strap, STPALPEE, Large, 1/CS
Published
2025-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKONegative pressure wound therapy non-powered suction apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKONegative Pressure Wound Therapy Non-Powered Suction ApparatusGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998028847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998028847001979980288471979980288470197998028847

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
102726734
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998301148Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998301162Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998303906Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™M8275065/5M8275065/52026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™M8275065/5 M8275065/10M8275065/5 M8275065/102026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™M8275081/5 M8275081/10M8275081/5 M8275081/102026-07-22
00849554005532SNAP™ STPAL2016-09-24
00849554005549SNAP™ STPALP2016-09-24
00849554005563SNAP™ STPASP2016-09-24
00849554005570SNAP™ STPAMP2016-09-24
00849554005587SNAP™ STPAS2016-09-24
108495540138623M™ V.A.C.®EZ5SMLV001 / EZ5SMLV002EZ5SML2024-03-05
108495540138793M™ V.A.C.®EZ5MEDV001 / EZ5MEDV002EZ5MED2024-03-05
108495540138863M™ V.A.C.®EZ5LRGV001 / EZ5LRGV002EZ5LRG2024-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998028809Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028816Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028823Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028830Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028854Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028861Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028878Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028885Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028892Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028908Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028915Solventum US LLCKCI USA, INC.OKO2025-07-23
00860004811381NPSealSTRYKER CORPORATIONOKO2024-10-22
00860004811398NPSealSTRYKER CORPORATIONOKO2024-10-22
008495540086323M™ Snap™KCI USA, INC.OKO2024-09-25
008495540086183M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086563M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086703M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086943M™ Snap™KCI USA, INC.OKO2024-08-09
008495540087173M™ Snap™KCI USA, INC.OKO2024-08-09
00860004811350NPSealSTRYKER CORPORATIONOKO2022-08-31
00860004811367NPSealSTRYKER CORPORATIONOKO2022-08-31
00860004811329NPseal MediumGuard Medical Inc.OKO2022-08-31
00860004811336NPseal LargeGuard Medical Inc.OKO2022-08-31
00860004811343NPSealSTRYKER CORPORATIONOKO2021-06-07
00860004811305NPseal (5)Guard Medical Inc.OKO2021-06-07
04719745008177AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008184AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008191AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008207AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008214AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09