FDA.reportPublic FDA data

Kolibri

Primary DI
05701780271608
Brand
Kolibri
Company
Coloplast A/S
Model
RJA114
Catalog number
RJA114
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
05701780271615PackageGS11In Commercial Distribution
05701780271622PackageGS124In Commercial Distribution
05701780271608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05701780271615057017802716155701780271615
05701780271622057017802716225701780271622
05701780271608057017802716085701780271608

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

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
05701780271639KolibriColoplast A/SLJE2023-01-20
05701780271660KolibriColoplast A/SLJE2023-01-20
05701780271691KolibriColoplast A/SLJE2023-01-20
05701780271721KolibriColoplast A/SLJE2023-01-20