CC1 Wound Drainage pump

Primary DI
08718104890459
Brand
CC1 Wound Drainage pump
Company
Meditop B.V.
Model
XL
Catalog number
3000700-CCT
Device description
The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from theapplication of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue(including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as thedevice may promote wound healing.
Published
2020-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082311000EXSUDEX WOUND DRAINAGE PUMPThe Medical Company2008-10-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718104890459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718104890459087181048904598718104890459

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, line-poweredAn assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and a mains electricity (AC-powered) computer-controlled vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure85 KiloPascal110 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31348566100info@meditop.nl

Regulatory Flags#

DUNS number
387209518
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718104890947Endo-SPONGE PumpXS55266502025-10-17
08718104890954Exsudex disposable canisterExsudex Disposable canister, 300 cc with filter an55266532025-10-17
08718104890473Exsudex disposable canisterCCT 1 disposable canister with tube and luer-lock 16670-LLA2021-02-27
08718104890480Exsudex disposable canisterCCT Mini disposable canister with tube and luer-lo16690-LLA2021-02-27
08718104890084Exsudex disposable canisterNewERA I disposable canister with tube16670-NEWERA2018-02-07
08718104890091Exsudex disposable canisterNewERA II disposable canister with tube and connec16690-NEWERA2018-02-07
08718104890107Exsudex disposable canisterLarge canister with tube166702018-02-07
08718104890114Exsudex disposable canisterLarge canister with luer-lock tube16670-LL2018-02-07
08718104890121Exsudex disposable canisterLarge canister without tube16670-HZS2018-02-07
08718104890145Exsudex disposable canisterCanister 300 ml with tube and connector166902018-02-07
08718104890152Exsudex disposable canisterCanister 300 ml with tube luer-lock16690-LL2018-02-07
08718104890008Exsudex Wound Drainage pumpXS30008002016-10-26
08718104890015Exsudex Wound Drainage PumpXL30007002017-01-26
08718104890466CCT Mini Wound Drainage pumpXS3000800-CCT2020-12-10
08718104890022NEWERA II Wound Drainage PumpXS3000800-IHT2016-10-26
08718104890039HALO MINI Wound Drainage PumpXS3000800-EQUINOX2016-10-26
08718104890046HALO XT Wound Drainage PumpXL3000700-HALOXT2016-10-26
08718104890053NEWERA I Wound Drainage PumpXL3000700-IHT2016-10-26
08718104890060RCI VAK Wound Drainage PumpXL3000700-RCIVAK2017-01-26
08718104890077JR VAK Wound Drainage PumpXS3000800-JRVAK2017-01-26