FDA.reportPublic FDA data

extriCARE

Primary DI
20879766005796
Brand
extriCARE
Company
OAKWELL DISTRIBUTION, INC.
Model
EC2400-SGS-7P-E
Device description
7 pieces of silicone gel strip
Published
2016-05-31
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

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110078000EXTRICAREDevon Medical Products, Inc.2012-02-10OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20879766005796PackageGS1250In Commercial Distribution
00879766005792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087976600579620879766005796
00879766005792008797660057928797660057920879766005792

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose low-vacuum suction systemAn assembly of devices designed to generate a low vacuum [typically <400 millimetre(s) of mercury (mmHg)] for a variety of clinical applications (e.g., thoracic drainage, negative pressure wound therapy, endoluminal vacuum therapy, subglottic suctioning); it may be software limited to a single intended use whereby upgrade is possible. It consists of a mains electricity (AC-powered) suction pump (which may include a rechargeable battery) with software, controls, and a pressure regulator, a collection canister(s), tubing, and bacteria filter; it may also include patient contact devices. The low vacuum level is intended to reduce the risk of trauma.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033337813
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00879766003590Nature's Bond6032016-05-31
00879766005235CircuFlowD-303R2016-05-30
00879766005266CironaF-102016-05-30
00879766005273CironaF-152016-05-30
00879766005280CironaD-1102016-05-30
00879766005297CironaD-1202016-05-30
00879766005303CironaD-1252016-05-30
00879766005310CironaD-1302016-05-30
00879766005327CironaD-1352016-05-30
00879766005334CironaD-1402016-05-30
00879766005341CironaD-1452016-05-30
00879766005402ArterioFlow75002016-05-30
00879766005419ArterioFlow75022016-05-30
00879766005426Cirona61002016-05-30
00879766005433Cirona62002016-05-30
00879766005440Cirona63002016-05-30
00879766005464extriCAREEC2400-E2016-05-30
00879766005471extriCAREEC3600-E2016-05-30
00879766005495extriCAREEC2400-100C-E2016-05-30
00879766005501extriCAREEC2400-400C-E2016-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14