FDA.reportPublic FDA data

Exsudex disposable canister

Primary DI
08718104890145
Brand
Exsudex disposable canister
Company
Meditop B.V.
Model
Canister 300 ml with tube and connector
Catalog number
16690
Device description
The Exsudex® Disposable Canister has the following features and is only to be used together with the Exsudex XS wound drainage system:- Canister capacity 300 cc;- Bacterial filter;- Fixed non-sterile suction tube with clamb and connector- Dissolving sachet solidifying agent
Published
2018-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718104890145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718104890145087181048901458718104890145

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
387209518
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
08718104890152Exsudex disposable canisterCanister 300 ml with tube luer-lock16690-LL2018-02-07
08718104890008Exsudex Wound Drainage pumpXS30008002016-10-26
08718104890015Exsudex Wound Drainage PumpXL30007002017-01-26
08718104890459CC1 Wound Drainage pumpXL3000700-CCT2020-12-10
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

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Primary DI, Brand, Company table
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