SpeediCath Flex Coude Pro 20012

GUDID 05708932765619

Coloplast A/S

Single-administration urethral drainage catheter
Primary Device ID05708932765619
NIH Device Record Key55014bd9-42c5-42d8-a8f6-2592fc01c8db
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Flex Coude Pro
Version Model Number20012
Catalog Number20012
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 Kitfalse
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
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
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 Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Working Length13 Inch
Catheter Gauge12 French
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932765602 [Primary]
GS105708932765619 [Package]
Contains: 05708932765602
Package: Retail Box [30 Units]
In Commercial Distribution
GS105708932765626 [Package]
Package: Shipper Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCATHETER, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-11

On-Brand Devices [SpeediCath Flex Coude Pro]

05708932674843Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932674812Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932674799Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932674751Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125499Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125468Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125437Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125413Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125383Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125352Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
05708932125314Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
0570893276589320014
0570893276561920012
0570893276549720010
0570893276613520016
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.