FDA.reportPublic FDA data

SpeediCath Flex Set

Primary DI
05708932755856
Brand
SpeediCath Flex Set
Company
Coloplast A/S
Model
28941
Catalog number
28941
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222059000SpeediCath Flex SetColoplast2022-09-21EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932755856PackageGS150In Commercial Distribution
05708932747684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932755856057089327558565708932755856
05708932747684057089327476845708932747684

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Catheter Working Length33Centimeter
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
05701780462129SenSura Mio Click13656136562026-11-02
05701780462136SenSura Mio Click13657136572026-11-02
05701780462143SenSura Mio Click13658136582026-11-02
05701780462150SenSura Mio Click13659136592026-11-02
05708932588942Freedom Clear5057415057412022-12-06
05708932957847Freedom Clear5057315057312022-12-06
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071078DoverCardinal Health 200, LLCFCM2026-06-24
10192253071115DoverCardinal Health 200, LLCFCM2026-06-24
10192253071122DoverCardinal Health 200, LLCFCM2026-06-24
14026704945990RUSCHTELEFLEX INCORPORATEDFCM2026-05-12
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
10192253028942DoverCardinal Health 200, LLCFCM2025-09-16
10704411019541AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019558AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019565AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019572AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019589AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01