SonoLong Echo NanoLine® NRFit 521165-31C

GUDID 04048223128589

SonoLong Echo NanoLine® NRFit SonoLong NanoLine® NRFit cannula Tuohy tip 18G x 100mm and

Pajunk GmbH Medizintechnologie

Peripheral anaesthesia catheter set, non-medicated
Primary Device ID04048223128589
NIH Device Record Key5e5c7b97-e568-45a0-befa-9bab568ffb56
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoLong Echo NanoLine® NRFit
Version Model Number521165-31C
Catalog Number521165-31C
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223117002 [Previous]
GS104048223126691 [Primary]
GS104048223128589 [Package]
Contains: 04048223126691
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAZAnesthesia conduction kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-25
Device Publish Date2025-06-17

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04048223051375 - SonoPlex® II NRFit2025-07-23 SonoPlex® II NRFit with Sprotte tip 22G (0,70) x 50mm with injection tube and connecting cable
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