FDA.reportPublic FDA data

Comfort Drain

Primary DI
EAMICDS20010
Brand
Comfort Drain
Company
AMI Agency for Medical Innovations GmbH
Model
CDS2001
Catalog number
CDS2001
Device description
The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facilitates drainage of perianal fistulas.
Published
2018-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBNCatheter, Pediatric, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBNCatheter, Pediatric, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAMICDS20011PackageHIBCC10In Commercial Distribution
EAMICDS20010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303655286
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
EAMIRAR20810RAR Flexi ProbeRAR2081RAR20812018-11-28
EAMIICT50100i-Cut Power SupplyICT50102025-05-05
EAMIICT50110i-CutICT5011ICT50112025-05-05
EAMIICT50500i-Cut Power Supply Type AICT50502025-05-05
EAMIECI10310A.M.I. EasyClinch Disposable Tips PremiumECI1031ECI10312019-04-05
EAMIECM10110EasyClinch microECM1011ECM10112019-04-05
EAMIEDI10310A.M.I. EasyDissect Disposable Tips PremiumEDI1031EDI10312019-04-05
EAMIEDI10510A.M.I. EasyHookEDI1051EDI10512019-04-05
EAMIEDM10110EasyDissect microEDM1011EDM10112019-04-05
EAMIESI11310A.M.I. EasyShear Disposable Tips PremiumESI1131ESI11312019-04-05
EAMIESI11510A.M.I. EasyShear Mini Disposable Tips PremiumESI1151ESI11512019-04-05
EAMIESI12100Soft InsertsESI1210ESI12102019-04-05
EAMIESM10110EasyShears microESM1011ESM10112019-04-05
EAMIEVI10110ViperEVI1011EVI10112019-04-05
EAMIEAH10100EasyAct HandleEAH1010EAH10102019-04-05
EAMIEAS13100EasyAct 3 SEAS1310EAS13102019-04-05
EAMIEAS13200EasyAct 3 MEAS1320EAS13202019-04-05
EAMIEAS15100EasyAct 5 SEAS1510EAS15102019-04-05
EAMIEAS15200EasyAct 5 MEAS1520EAS15202019-04-05
EAMIEAS15300EasyAct 5 LEAS1530EAS15302019-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850005416026MedDrainARMM INC.GBN2023-06-08
10850005416057MedDrainARMM INC.GBN2023-06-08
10850005416064MedDrainARMM INC.GBN2023-06-08
10850082007971MedDrainARMM INC.GBN2023-06-08
10850082007988MedDrainARMM INC.GBN2023-06-08
00850005416029MedDrainARMM INC.GBN2023-06-08
00850005416050MedDrainARMM INC.GBN2023-06-08
00850005416067MedDrainARMM INC.GBN2023-06-08
00850082007974MedDrainARMM INC.GBN2023-06-08
00850082007981MedDrainARMM INC.GBN2023-06-08
00817213021537NATIONAL HOSPITAL PACKAGINGSurgi-Pak, Inc.GBN2022-12-06
EAMICDS20100Comfort Drain GrasperAMI Agency for Medical Innovations GmbHGBN2018-11-29
10850082007865MedDrainARMM INC.GBN2018-11-02
10850082007872MedDrainARMM INC.GBN2018-11-02
10850082007933MedDrainARMM INC.GBN2018-11-02
10850082007940MedDrainARMM INC.GBN2018-11-02
10850082007957MedDrainARMM INC.GBN2018-11-02