FDA.reportPublic FDA data

Kolibri

Primary DI
05701780271363
Brand
Kolibri
Company
Coloplast A/S
Model
RCM012
Catalog number
RCM012
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
05701780271363PackageGS15In Commercial Distribution
05701780271387PackageGS124In Commercial Distribution
05701780271356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05701780271363057017802713635701780271363
05701780271387057017802713875701780271387
05701780271356057017802713565701780271356

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14
00762123030196Conveen Security+21346213462022-03-11
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08

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