LoFric® 4010640

GUDID 07333387035307

Single Use Urinary Catheter LoFric Nelaton 8" 06FR Paediatric

Wellspect AB

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter
Primary Device ID07333387035307
NIH Device Record Key114c5560-fc2c-4c76-a988-8abef809a4da
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFric®
Version Model Number40106
Catalog Number4010640
Company DUNS351118942
Company NameWellspect AB
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com

Device Dimensions

Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French
Length8 Inch
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS107333387035178 [Primary]
GS107333387035307 [Package]
Contains: 07333387035178
Package: [30 Units]
In Commercial Distribution
GS107333387035314 [Package]
Package: [4 Units]
In Commercial Distribution
GS107392532135200 [Previous]

FDA Product Code

EZDCatheter, straight

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-03
Device Publish Date2023-09-25

On-Brand Devices [LoFric®]

07333387040486Single Use Urinary Catheter LoFric Coudé 16" 16FR
07333387035604Single Use Urinary Catheter LoFric Nelaton 8" 08FR Paediatric
07333387034171Single Use Urinary Catheter LoFric Nelaton 16" 16FR
07333387033877Single Use Urinary Catheter LoFric Nelaton 16" 14FR
07333387033570Single Use Urinary Catheter LoFric Nelaton 16" 12FR
07333387033266Single Use Urinary Catheter LoFric Nelaton 16" 10FR
07333387040776Single Use Urinary Catheter LoFric Coudé 16" 18FR
07333387040172Single Use Urinary Catheter LoFric Coudé 16" 14FR
07333387039879Single Use Urinary Catheter LoFric Coudé 16" 12FR
07333387039572Single Use Urinary Catheter LoFric Coudé 16" 10FR
07333387039312Single Use Urinary Catheter LoFric Nelaton 6" 14FR
07333387039046Single Use Urinary Catheter LoFric Nelaton 6" 12FR
07333387038766Single Use Urinary Catheter LoFric Nelaton 6" 10FR
07333387038506Single Use Urinary Catheter LoFric Nelaton 6" 08FR
07333387038223Single Use Urinary Catheter LoFric Nelaton 8" 18FR
07333387037967Single Use Urinary Catheter LoFric Nelaton 8" 16FR
07333387037660Single Use Urinary Catheter LoFric Nelaton 8" 14FR
07333387037363Single Use Urinary Catheter LoFric Nelaton 8" 12FR
07333387037066Single Use Urinary Catheter LoFric Nelaton 8" 10FR
07333387036793Single Use Urinary Catheter LoFric Nelaton 8" 08FR
07333387036502Single Use Urinary Catheter LoFric Nelaton 12" 10FR Paediatric
07333387036229Single Use Urinary Catheter LoFric Nelaton 12" 08FR Paediatric
07333387035871Single Use Urinary Catheter LoFric Nelaton 8" 10FR Paediatric
07333387035307Single Use Urinary Catheter LoFric Nelaton 8" 06FR Paediatric
07333387035031Single Use Urinary Catheter LoFric Nelaton 16" 22FR
07333387034775Single Use Urinary Catheter LoFric Nelaton 16" 20FR
07333387034461Single Use Urinary Catheter LoFric Nelaton 16" 18FR
07333387033006Single Use Urinary Catheter LoFric Nelaton 16" 08FR

Trademark Results [LoFric]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOFRIC
LOFRIC
73423764 1324299 Live/Registered
Astra Meditec Aktiebolag
1983-04-29

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