FDA.reportPublic FDA data

SpeediCath Flex Set

Primary DI
05708932778275
Brand
SpeediCath Flex Set
Company
Coloplast A/S
Model
28942
Catalog number
28942
Published
2026-02-05
Public version status
New
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
EZDCatheter, straight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, 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
05708932778275PackageGS150In Commercial Distribution
05708932778121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932778275057089327782755708932778275
05708932778121057089327781215708932778121

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Catheter Working Length13Inch
Catheter Working Length33Centimeter
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

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
05701780348317Luja SoftColoplast A/SEZD2026-10-01
05701780348348Luja SoftColoplast A/SEZD2026-10-01
05701780348379Luja SoftColoplast A/SEZD2026-10-01
05701780348409Luja SoftColoplast A/SEZD2026-10-01
07333387059730LoFric OrigoWellspect ABEZD2026-08-28
07333387059754LoFric OrigoWellspect ABEZD2026-08-28
07333387059778LoFric OrigoWellspect ABEZD2026-08-28
00610075096121VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096138VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096145VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096152VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096169VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096176VaProHOLLISTER INCORPORATEDEZD2026-06-06
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22