E-Cath® NRFit Tsui® 241265-40E

GUDID 04048223086155

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: 04048223086155
• NIH Device Record Key: abe7c77d-77ba-488d-ac3d-c1f35a7e8b6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Cath® NRFit Tsui®
• Version Model Number: 241265-40E
• Catalog Number: 241265-40E
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223065570 [Primary]
GS1	04048223086155 [Unit of Use]

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

Devices Manufactured by Pajunk GmbH Medizintechnologie

• 04048223123140 - BRAINPRO: 2023-03-29 41778C
• 04048223113820 - SPROTTE®: 2022-03-03 Needle
• 04048223078532 - SONOTAP II: 2021-07-27 CornerStonesProximal End: ISO 80369-7
• 04048223112700 - QUINCKE: 2021-07-21 1149-3K152
• 04048223115770 - MULTISTIM VARIO: 2021-07-21 1151-94-02
• 04048223075791 - MULTISTIM VARIO: 2021-07-21 1151-94-05
• 04048223086155 - E-Cath® NRFit Tsui®: 2021-07-20
• 04048223086155 - E-Cath® NRFit Tsui®: 2021-07-20
• 04048223111802 - TUOHY: 2021-07-20 Tuohy-Kanüle mit Griffplatte