FDA.reportPublic FDA data

extriCARE

Primary DI
10879766005478
Brand
extriCARE
Company
OAKWELL DISTRIBUTION, INC.
Model
EC3600-E
Device description
3600 Pump set with one canister in a box
Published
2016-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K132225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132225000EXTRICAREDevon Medical, Inc.2014-05-15OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879766005478PackageGS14In Commercial Distribution
00879766005471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087976600547810879766005478
00879766005471008797660054718797660054710879766005471

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
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05