E-Cath® II Plus Tsui® NRFit 311165-41E

GUDID 04048223122150

E-Cath® II Plus Tsui® NRFit SonoPlex® II Facet S NRFit 21G with indwelling catheter 18G x 80mm

Pajunk GmbH Medizintechnologie

Peripheral anaesthesia catheter set, non-medicated

• Primary Device ID: 04048223122150
• NIH Device Record Key: 03de8f1b-bd69-4bab-aa22-1e5759f94a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Cath® II Plus Tsui® NRFit
• Version Model Number: 311165-41E
• Catalog Number: 311165-41E
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge
• Length: 80 Millimeter
• Needle Gauge: 18 Gauge

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 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	04048223122143 [Primary]
GS1	04048223122150 [Package]; Contains: 04048223122143; Package: [10 Units]; In Commercial Distribution

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: 2025-02-07
• Device Publish Date: 2025-01-30

On-Brand Devices [E-Cath® II Plus Tsui® NRFit]

• 04048223122150: E-Cath® II Plus Tsui® NRFit SonoPlex® II Facet S NRFit 21G with indwelling catheter 18G x 80m
• 04048223122136: E-Cath® II Plus Tsui® NRFit SonoPlex® II Facet S NRFit 21G with indwelling catheter 18G x 50m