Self-Cath Closed System 50281

GUDID 05708932283014

Self-Cath Closed System. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. FR 14. Rx only.

Coloplast A/S

Single-administration urethral catheterization kit, single-use

Primary Device ID	05708932283014
NIH Device Record Key	5cf45069-ae8b-4b45-9b53-e221c1a7f7f1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Self-Cath Closed System
Version Model Number	50281
Catalog Number	50281
Company DUNS	305524696
Company Name	Coloplast A/S
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0
Catheter Gauge	14 French
Catheter Working Length	5.2 Inch
Catheter Working Length	13 Centimeter
Device Size Text, specify	0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932279536 [Primary]
GS1	05708932283014 [Package] Contains: 05708932279536 Package: Shipper box [50 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070939

FDA Product Code

EZD	CATHETER, STRAIGHT
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-02

On-Brand Devices [Self-Cath Closed System]

05708932283083	Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Con
05708932283090	Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Con
05708932283076	Self-Cath Closed System Kit. Taper Tip. Male. Pre-lubricated Urinary Catheterization System. Con
05708932283069	Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System
05708932283052	Self-Cath Closed System Kit. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. Co
05708932283045	Self-Cath Closed System. Olive Tip. Male. Pre-lubricated Urinary Catheterization System. FR 16.
05708932283038	Self-Cath Closed System. Olive Tip. Male. Pre-lubricated Urinary Catheterization System. FR 14.
05708932283021	Self-Cath Closed System. Taper Tip. Male. Pre-lubricated Urinary Catheterization System. FR 14.
05708932283014	Self-Cath Closed System. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. FR
05708932282994	Self-Cath Closed System. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR 14.
05708932282987	Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
05708932282970	Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
05708932282963	Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
05708932282956	Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
05708932282949	Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
05708932282932	Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
05708932282925	Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
05708932282918	Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
05708932282901	Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
05708932282895	Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System