Self Cath 50513

GUDID 05708932279888

Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR 14. 16 in. 40 cm. Rx only.

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932279888
• NIH Device Record Key: 3fde69b1-64e2-4324-ba2a-5e3f256d78c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self Cath
• Version Model Number: 50513
• Catalog Number: 50513
• 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
• 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

• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 40 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter
• Catheter Gauge: 14 French
• Catheter Working Length: 14.9 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 38 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if sterile barrier is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• 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.
• 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	05708932279871 [Package]; Contains: 05708932999366; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932279888 [Package]; Contains: 05708932279871; Package: Shipper box [12 Units]; In Commercial Distribution
GS1	05708932999366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003784

FDA Product Code

• EZD: CATHETER, STRAIGHT

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: 2016-09-22

On-Brand Devices [Self Cath]

• 05708932278614: Self-Cath. Urinary Catheter. Straight Tip Female. FR 12. 6 in. 16 cm Rx only.
• 05708932278638: Self-Cath. Urinary Catheter. Straight Tip Female. FR 14. 6 in. 16 cm Rx only.
• 05708932278683: Self-Cath. Urinary Catheter. Luer End Pediatric. FR 10. 10 in. 25 cm Rx only.
• 05708932278713: Self-Cath. Urinary Catheter. Straight Tip Male. FR 10. 16 in. 40 cm Rx only.
• 05708932278904: Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 10. 16 in. 40 cm Rx only.
• 05708932279000: Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 6. 16 in. 40 cm Rx only.
• 05708932279031: Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 8. 16 in. 40 cm Rx only.
• 05708932279086: Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 14. 16 in. 40 cm Rx only.
• 05708932279802: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 18. 16 in. 40 cm. Rx
• 05708932279826: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe Male. FR 8
• 05708932279918: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 10
• 05708932279987: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 16
• 05708932278751: Self-Cath. Urinary Catheter. Straight Tip Male. FR 16. 16 in. 40 cm Rx only.
• 05708932278942: Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 14. 16 in. 40 cm
• 05708932277150: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Female. FR 10. 6 in. 16 cm. R
• 05708932279833: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR
• 05708932279888: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR
• 05708932279895: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 8.
• 05708932279932: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 12