FixoLong 001163-60

GUDID 04048223118702

FixoLong Fixation system for Catheter and Filter

Pajunk GmbH Medizintechnologie

Adhesive bandage
Primary Device ID04048223118702
NIH Device Record Keyef5e9160-1477-45f8-93ac-80e7206a59c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixoLong
Version Model Number001163-60
Catalog Number001163-60
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer
Pore Size0.2 Micrometer

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223118696 [Primary]
GS104048223118702 [Package]
Contains: 04048223118696
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KGZACCESSORIES, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-14
Device Publish Date2025-04-04

On-Brand Devices [FixoLong]

14048223037444Adhesive tape with catheter cross, Filteradapter and Bacterial Filter sterile
14048223009588FixoLong Fixationsystem for Catheter and Filter:
04048223009581001151-41
04048223037447001151-48
04048223118702FixoLong Fixation system for Catheter and Filter

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