FDA.reportPublic FDA data

Exodus

Primary DI
H965104221
Brand
Exodus
Company
NAVILYST MEDICAL, INC.
Model
10422
Device description
12F x 25cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJECATHETER, NEPHROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965104221PackageHIBCC5In Commercial Distribution
H965104220PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length25Centimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356554807TriousShenzhen Trious Medical Technology Co., Ltd.LJE2026-04-27
06973356554777TriousShenzhen Trious Medical Technology Co., Ltd.LJE2026-03-27
00860000917506RetroPercRETROPERC INC.LJE2025-01-09
00812261011813allSoftALLWIN MEDICAL DEVICES, INC.LJE2024-01-09
05701780270861KolibriColoplast A/SLJE2023-01-20
05701780270892KolibriColoplast A/SLJE2023-01-20
05701780270922KolibriColoplast A/SLJE2023-01-20
05701780270953KolibriColoplast A/SLJE2023-01-20
05701780270984KolibriColoplast A/SLJE2023-01-20
05701780271059KolibriColoplast A/SLJE2023-01-20
05701780271080KolibriColoplast A/SLJE2023-01-20
05701780271110KolibriColoplast A/SLJE2023-01-20
05701780271141KolibriColoplast A/SLJE2023-01-20
05701780271172KolibriColoplast A/SLJE2023-01-20
05701780271202KolibriColoplast A/SLJE2023-01-20
05701780271233KolibriColoplast A/SLJE2023-01-20
05701780271264KolibriColoplast A/SLJE2023-01-20
05701780271295KolibriColoplast A/SLJE2023-01-20
05701780271325KolibriColoplast A/SLJE2023-01-20
05701780271356KolibriColoplast A/SLJE2023-01-20
05701780271394KolibriColoplast A/SLJE2023-01-20
05701780271424KolibriColoplast A/SLJE2023-01-20
05701780271455KolibriColoplast A/SLJE2023-01-20
05701780271486KolibriColoplast A/SLJE2023-01-20
05701780271530KolibriColoplast A/SLJE2023-01-20
05701780271561KolibriColoplast A/SLJE2023-01-20
05701780271608KolibriColoplast A/SLJE2023-01-20
05701780271639KolibriColoplast A/SLJE2023-01-20
05701780271660KolibriColoplast A/SLJE2023-01-20
05701780271691KolibriColoplast A/SLJE2023-01-20