E-CATH TSUI 271285-41E

GUDID 04048223113813

271285-41E

Pajunk GmbH Medizintechnologie

Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated

• Primary Device ID: 04048223113813
• NIH Device Record Key: 501f6af4-143b-4dcf-abda-311478036858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-CATH TSUI
• Version Model Number: 271285-41E
• Catalog Number: 271285-41E
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223065891 [Previous]
GS1	04048223113813 [Unit of Use]
GS1	04048223116623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152952

FDA Product Code

• BSO: CATHETER, CONDUCTION, ANESTHETIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-20
• Device Publish Date: 2021-07-12

On-Brand Devices [E-CATH TSUI]

• 04048223037355: 271285-41E
• 04048223035757: 271285-40E
• 04048223037362: 261285-41E
• 04048223037379: 261285-40E
• 04048223037331: 251285-41E
• 04048223037348: 251285-40E
• 04048223037317: 251185-41E
• 04048223037270: 251185-40E
• 04048223037201: 241285-41E
• 04048223037249: 241285-40E
• 04048223037300: 241185-41E
• 04048223037232: 241185-40E
• 04048223030172: 211285-41E
• 04048223037263: 211285-40E
• 04048223037294: 211185-41E
• 04048223037225: 211185-40E
• 04048223037324: 201285-41E
• 04048223037256: 201285-40E
• 04048223037287: 201185-41E
• 04048223037218: 201185-40E
• 04048223113806: 271285-40E
• 04048223113790: 261285-41E
• 04048223113783: 261285-40E
• 04048223113745: 241285-40E
• 04048223113738: 241185-41E
• 04048223113721: 241185-40E
• 04048223113691: 211285-41E
• 04048223113684: 211185-41E
• 04048223113677: 211185-40E
• 04048223113646: 201285-41E
• 04048223113639: 201285-40E
• 04048223113622: 201185-41E
• 04048223113615: 201185-40E
• 04048223113813: 271285-41E