FDA.reportPublic FDA data

SNAP™

Primary DI
00849554005464
Brand
SNAP™
Company
KCI USA, INC.
Model
SKTF15X15
Device description
Snap Therapy System Snap Advanced Dressing Kit15 cm X 15 cm Dressing Kit13 cm X 13 cm Foam
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112341000SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-08-29OKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849554007017PackageGS110In Commercial Distribution
20849554005468PackageGS110In Commercial Distribution
00849554005464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554007017008495540070178495540070170849554007017
2084955400546820849554005468
00849554005464008495540054648495540054640849554005464

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

Regulatory Flags#

DUNS number
102726734
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
008495540080143M™ Prevena Restor™ Adaptiform™PRE6001PRE60012022-08-18
008495540083733M™ Prevena Restor™ Adaptiform™PRE6055PRE60552022-08-18
00197998028922Solventum US LLCABT1055ABT10552025-07-29
00197998028946Solventum US LLCABT1055ABT10552025-07-29
00197998032608Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312267Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028939Solventum US LLCABT1055ABT10552025-07-29
00197998028953Solventum US LLCABT1055ABT10552025-07-29
00197998032615Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312274Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028809Solventum US LLCSTPASSTPAS2025-07-23
00197998028816Solventum US LLCSTPAMPSTPAMP2025-07-23

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
00197998028847Solventum 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