FDA.reportPublic FDA data

Exsudex disposable canister

Primary DI
08718104890091
Brand
Exsudex disposable canister
Company
Meditop B.V.
Model
NewERA II disposable canister with tube and connec
Catalog number
16690-NEWERA
Device description
The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system:- Canister capacity 300 cc;- Bacterial filter;- Fixed non-sterile suction tube with clamb and luer-lock connector- Dissolving sachet solidifying agent
Published
2018-02-07
Public version status
Update
Distribution status
Not 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
08718104890091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718104890091087181048900918718104890091

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
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
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
Primary DIBrandCompanyProduct codePublished
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08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
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50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
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