Customised Convenience Kit 0431157-848

GUDID 04048223129210

Customised Convenience Kit Type "Epilong Soft" 1 x Three Compartment Tray

Pajunk GmbH Medizintechnologie

Epidural anaesthesia set, non-medicated

• Primary Device ID: 04048223129210
• NIH Device Record Key: 158aa42a-29b1-4a88-89e2-fd9b84548b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Customised Convenience Kit
• Version Model Number: 0431157-848
• Catalog Number: 0431157-848
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• 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: 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
• 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
• 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 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223115169 [Previous]
GS1	04048223127322 [Primary]
GS1	04048223129210 [Package]; Contains: 04048223127322; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060311

FDA Product Code

• CAZ: Anesthesia conduction kit

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: 2025-06-25
• Device Publish Date: 2025-06-17

On-Brand Devices [Customised Convenience Kit]

• 04048223129210: Customised Convenience Kit Type "Epilong Soft" 1 x Three Compartment Tray
• 04048223106600: Customised Convenience Kit Type "SonoTAP® - Dual Catheter Set" 1 x Tuohy Sono cannula 18G x 150