FDA.reportPublic FDA data

Exsudex disposable canister

Primary DI
87181048900848
Brand
Exsudex disposable canister
Company
Meditop B.V.
Model
NewERA I disposable canister with tube
Catalog number
16670-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
Published
2018-02-07
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
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
87181048900848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8718104890084887181048900848

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container made of glass or plastic (typically chemical resistant) 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 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
DM exempt
false
Premarket exempt
true
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
08718104891890CCT-PREVENT Mini Wound Drainage pumpXS3000800-CCT2026-06-23
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
00630094061511Bioseal Inc.BIOSEALGCY2024-01-29
00630094061528Bioseal Inc.BIOSEALGCY2024-01-29
00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
00630094043807Bioseal Inc.BIOSEALGCY2024-01-19
00630094043814Bioseal Inc.BIOSEALGCY2024-01-19
00630094192222Bioseal Inc.BIOSEALGCY2023-12-07
00630094196800Bioseal Inc.BIOSEALGCY2023-11-29
00630094196817Bioseal Inc.BIOSEALGCY2023-11-29
00630094196824Bioseal Inc.BIOSEALGCY2023-11-29
00630094196831Bioseal Inc.BIOSEALGCY2023-11-29
00630094196855Bioseal Inc.BIOSEALGCY2023-11-29
00630094196862Bioseal Inc.BIOSEALGCY2023-11-29
00630094196879Bioseal Inc.BIOSEALGCY2023-11-29