GENTLECATH TIEMANN 501011

GUDID 00768455145508

TIEMANN CH08X16 IN

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral drainage catheter

• Primary Device ID: 00768455145508
• NIH Device Record Key: b02e17e9-3400-4bb4-a548-cc2212acab79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTLECATH TIEMANN
• Version Model Number: 501011
• Catalog Number: 501011
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
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• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
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• Email: cic@convatec.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455111497 [Package]; Package: Carton [100 Units]; In Commercial Distribution
GS1	00768455145508 [Primary]
GS1	10768455111494 [Package]; Contains: 00768455111497; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161344
• Premarket Notification: K172924

FDA Product Code

• KOD: Catheter, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [GENTLECATH TIEMANN]

• 00768455145553: TIEMANN CH18X16 IN
• 00768455145546: TIEMANN CH16X16 IN
• 00768455145539: TIEMANN CH14X16 IN
• 00768455145522: TIEMANN CH12X16 IN
• 00768455145515: TIEMANN CH10X16 IN
• 00768455145508: TIEMANN CH08X16 IN