LineLogic™

GUDID 10851780008109

Sterile, Linelogic™ 7 Fr Catheter Stabilization Device

SMD Manufacturing LLC

Wearable percutaneous catheter/tube holder
Primary Device ID10851780008109
NIH Device Record Key7d870eff-da61-4816-9467-efe17a0289a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLineLogic™
Version Model NumberLL-M-7
Company DUNS070849038
Company NameSMD Manufacturing LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health
Phone+1 (801) 899-3036
Emailinfo@linelogic.health

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100851780008102 [Primary]
GS110851780008109 [Package]
Contains: 00851780008102
Package: Box [10 Units]
In Commercial Distribution
GS120851780008106 [Package]
Package: Case [2 Units]
In Commercial Distribution
GS130851780008103 [Package]
Contains: 20851780008106
Package: Overshipper [16 Units]
In Commercial Distribution

FDA Product Code

KMKDevice, Intravascular Catheter Securement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [LineLogic™]

10851780008208Sterile, Linelogic™ 8.5 Fr Catheter Stabilization Device
10851780008109Sterile, Linelogic™ 7 Fr Catheter Stabilization Device
10851780008000Sterile, Linelogic™ 6 Fr Catheter Stabilization Device

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