FDA.reportPublic FDA data

LineLogic™

Primary DI
00851780008003
Brand
LineLogic™
Company
SMD Manufacturing LLC
Model
LL-M-6
Device description
Sterile, Linelogic™ 6 Fr Catheter Stabilization Device
Published
2022-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10851780008000PackageGS110In Commercial Distribution
20851780008007PackageGS12In Commercial Distribution
30851780008004PackageGS116In Commercial Distribution
00851780008003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085178000800010851780008000
2085178000800720851780008007
3085178000800430851780008004
00851780008003008517800080038517800080030851780008003

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holder, single-useA noninvasive device designed to fix a percutaneous (excluding intracranial) catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body; 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, a base plate, strip, or bandage that will attach to the patient's skin, and may include holes to allow suture fixation. The exposed side may have integrated fixation mechanism to hold the catheter/tube in place and 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 Gauge6French

Contacts#

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

Regulatory Flags#

DUNS number
070849038
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10851780008208LineLogic™LL-M-82022-08-01
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