SpeediCath Flex Set 28941

GUDID 05708932778268

Coloplast A/S

Single-administration urethral catheterization kit, single-use
Primary Device ID05708932778268
NIH Device Record Key0633afae-1d3d-4532-a7eb-b014b6c66808
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Flex Set
Version Model Number28941
Catalog Number28941
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Catheter Working Length13 Inch
Catheter Gauge10 French
Catheter Working Length33 Centimeter
Device Size Text, specify0
Catheter Working Length13 Inch
Catheter Gauge10 French
Catheter Working Length33 Centimeter
Device Size Text, specify0
Catheter Working Length13 Inch
Catheter Gauge10 French
Catheter Working Length33 Centimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932778114 [Primary]
GS105708932778268 [Package]
Contains: 05708932778114
Package: Shipper Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-13
Device Publish Date2026-02-05

On-Brand Devices [SpeediCath Flex Set]

05701780221559SpeediCath Flex Set CH16
05701780221658SpeediCath Flex Set CH14
05701780221641SpeediCath Flex Set CH12
05701780221627SpeediCath Flex Set CH10
0570893275308128946
0570893275589428944
0570893275587028942
0570893275585628941
0570893277828228946
0570893277827528942
0570893277826828941

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