Filter NRFit 001163-39F

GUDID 04048223041796

Filter NRFit

Pajunk GmbH Medizintechnologie

Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter Anaesthesia conduction filter

• Primary Device ID: 04048223041796
• NIH Device Record Key: ba419114-a940-4399-ac90-346fa1571b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filter NRFit
• Version Model Number: 001163-39F
• Catalog Number: 001163-39F
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223041796 [Unit of Use]
GS1	04048223050064 [Primary]
GS1	14048223041793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190663

FDA Product Code

• BSN: FILTER, 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: 2020-07-30
• Device Publish Date: 2020-07-22

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
• 04048223111802 - TUOHY: 2021-07-20 Tuohy-Kanüle mit Griffplatte