LoFric® Sense™ 4161405

GUDID 07333387023083

Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH14 / Nelaton 6" 14FR, 5-pack. For females. Sterile device.

Wellspect AB

Single-administration urethral catheterization kit, single-use
Primary Device ID07333387023083
NIH Device Record Key77caac0d-cf3c-4967-87fc-9ac4dc6c4c92
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFric® Sense™
Version Model Number4161425
Catalog Number4161405
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 French
Length6 Inch
Catheter Gauge14 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
GS107333387023083 [Package]
Contains: 07333387023182
Package: [5 Units]
In Commercial Distribution
GS107333387023182 [Primary]
GS107392532086489 [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® Sense™]

07333387023335Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH14 / Nelaton 6" 14FR
07333387023083Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH14 / Nelaton 6" 14F
07333387022611Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH12 / Nelaton 6" 12FR
07333387022369Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH12 / Nelaton 6" 12F
07333387021638Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH10 / Nelaton 6" 10F
07333387021232Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH08 / Nelaton 6" 08FR
07333387020990Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH08 / Nelaton 6" 08F
07333387021898Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH10 / Nelaton 6" 10FR

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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