SpeediCath Compact 28422

GUDID 05708932534475

SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. For males only . L

Coloplast A/S

Single-administration urethral drainage catheter
Primary Device ID05708932534475
NIH Device Record Key507aa8fe-19a6-4d16-b4fb-96e3445ddfbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Compact
Version Model Number28422
Catalog Number28422
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 Latexfalse
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

Device Dimensions

Outer Diameter4 Millimeter
Catheter Gauge12 French
Total Volume750 Milliliter
Device Size Text, specify0
Device Size Text, specify0
Length11.8 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter
Catheter Gauge12 French
Catheter Working Length11.8 Inch
Device Size Text, specify0
Catheter Working Length30 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932024648 [Package]
Contains: 05708932967150
Package: Sample pack [5 Units]
In Commercial Distribution
GS105708932534468 [Package]
Contains: 05708932967150
Package: Retail box [20 Units]
In Commercial Distribution
GS105708932534475 [Package]
Contains: 05708932534468
Package: Shipper box [3 Units]
In Commercial Distribution
GS105708932967150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCATHETER, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

On-Brand Devices [SpeediCath Compact]

05708932534475SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea
05708932534482SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea
05708932653053SpeediCath Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to u
05708932640572SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe
05708932624688SpeediCath Compact Male Kit. Compact with SpeediBag. Urinary catheter for intermittent catheteri
05708932618755SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate
05708932618724SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate
05708932618700SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate
05708932579018SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe
05708932543965SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea
05708932543941SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea
05708932024754SpeediCath Compact with SpeediBag sample pack. Urinary catheter for intermittent catheterization
05708932024709SpeediCath Compact Male Kit sample pack. Compact with SpeediBag. Urinary catheter for intermitte
05708932558952SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated
05708932558921SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated
05708932558907SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated
05708932640527SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe
05708932640534SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe
05708932024693SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe
05708932020558SpeediCath Compact female CH10
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