FDA.reportPublic FDA data

LineLogic™

Primary DI
10851780008208
Brand
LineLogic™
Company
SMD Manufacturing LLC
Model
LL-M-8
Device description
Sterile, Linelogic™ 8.5 Fr Catheter Stabilization Device
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851780008208PackageGS110In Commercial Distribution
20851780008205PackageGS12In Commercial Distribution
30851780008202PackageGS116In Commercial Distribution
00851780008201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085178000820810851780008208
2085178000820520851780008205
3085178000820230851780008202
00851780008201008517800082018517800082010851780008201

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holderA device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.6French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (801) 899-3036info@linelogic.health

Regulatory Flags#

DUNS number
070849038
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851780008003LineLogic™LL-M-62022-08-01
00851780008102LineLogic™LL-M-72022-08-01
00851780008201LineLogic™LL-M-82022-08-01
00850001175029ReddyPortRP-541-L12024-01-16
00850001175067ReddyPortRP-541-L22024-01-16
00850001175074ReddyPortRP-541-SE2024-01-16
10850001175026ReddyPortRP-541-L12024-01-16
10850001175064ReddyPortRP-541-L22024-01-16
10850001175071ReddyPortRP-541-SE2024-01-16
00850001175227ReddyPortRP-MKITQ4-22023-07-12
10850001175224ReddyPortRP-MKITQ4-22023-07-12
10851780008000LineLogic™LL-M-62022-08-01
10851780008109LineLogic™LL-M-72022-08-01
00850001175210ReddyPortRP-MKITQ4-12020-11-18
10850001175217ReddyPortRP-MKITQ4-12020-11-18
00850001175203Moisturizer RP-MPK-12020-11-18
00850001175005ReddyPortRP-531-L12020-10-28
10850001175002ReddyPortRP-531-L12020-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10618125192592Grip-LokTIDI PRODUCTS, LLCKMK2026-06-09
00850087488303CeeportCEEPORT INC.KMK2026-05-29
00850087488310CeeportCEEPORT INC.KMK2026-05-29
00850087488327CeeportCEEPORT INC.KMK2026-05-29
00850087488334CeeportCEEPORT INC.KMK2026-05-29
00850087488341CeeportCEEPORT INC.KMK2026-05-29
00850087488358CeeportCEEPORT INC.KMK2026-05-29
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21