FDA.reportPublic FDA data

Modulare Stabilization Device

Primary DI
00013964672237
Brand
Modulare Stabilization Device
Company
INSIGHTRA MEDICAL, INC.
Model
M-CVC/PICCSP
Device description
The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.
Published
2015-03-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00013964672244PackageGS120Not in Commercial Distribution
00013964672251PackageGS150Not in Commercial Distribution
00013964672268PackageGS1120Not in Commercial Distribution
00013964672275PackageGS1300Not in Commercial Distribution
00013964672237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00013964672244000139646722440139646722440013964672244
00013964672251000139646722510139646722510013964672251
00013964672268000139646722680139646722680013964672268
00013964672275000139646722750139646722750013964672275
00013964672237000139646722370139646722370013964672237

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.

Contacts#

Phone, Email table
PhoneEmail
949-215-1835raqa@insightra.com
9319192955wayne.lyle@insightra.com

Regulatory Flags#

DUNS number
097664937
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
00013964672077Modulare Stabilization DeviceM-CVC/PICC2015-03-16
00850012832010Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmFIHR 25mm2015-07-22
00850012832072Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmFIHR 40mm2015-07-22
00850012832102Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmEFIHR 40mmE2015-07-22
00850012832218Freedom - Ventral Hernia Repair SystemFVHR12X15FVHR12X152015-07-22
00850012832287Freedom - Ventral Hernia Repair SystemFVHR20X30FVHR20X302015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemFVHR28X35FVHR28X352015-07-22
00850012832041Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmEFIHR 25mmE2015-07-22
00850012832256Freedom - Ventral Hernia Repair SystemFVHR15X25FVHR15X252015-07-22
00850012832348Freedom - Ventral Hernia Repair SystemFVHR35X45FVHR35X452015-07-22
00013964672152Freedom - ProFlor Inguinal Hernia KitFIHR 40mmEKFIHR 40mmEK2015-07-22
00013964672367Freedom - ProFlor Inguinal Hernia KitFIHR 25mmEKFIHR 25mmEK2015-07-22
00837654352878Freedom - ProFlor Inguinal Hernia KitFIHR 25mmKFIHR 25mmK2015-07-22
00837654352885Freedom - ProFlor Inguinal Hernia KitFIHR 40mmKFIHR 40mmK2015-07-22
17350021986129PowerPumpTM dp System Day Cassette9410122016-09-24
17350021986136PowerPumpTM dp System Patient cassette9410132016-09-24
17350021986143PowerPumpTM dp System Patient tubing9410142016-09-24
07350021981004Double Pump Day cassette/ Double Pump RF Day cassette10020532016-09-24
07350021981509Double Pump Single/ Double Pump RF Single10020522016-09-24
07350021982001Double Pump Patient cassette10020592016-09-24

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