FDA.reportPublic FDA data

SecurAcath

Primary DI
00865382000280
Brand
SecurAcath
Company
INTERRAD MEDICAL, INC
Model
12F
Catalog number
400200
Published
2020-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
OKCImplanted Subcutaneous Securement Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2
OKCImplanted Subcutaneous Securement CatheterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865382000287PackageGS110In Commercial Distribution
00865382000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086538200028710865382000287
00865382000280008653820002808653820002800865382000280

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 Gauge12French

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555472310
Device count
1
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
00865382000204SecurAcath3F4001302016-09-15
00865382000211SecurAcath4F4001402016-09-15
00865382000228SecurAcath5F4001102016-09-15
00865382000235SecurAcath6F4001502016-09-15
00865382000242SecurAcath7F4001202016-09-15
00865382000259SecurAcath8F4001602016-09-15
00865382000297SecurAcath10F4001802020-06-03
10865382000201SecurAcath3F4001302016-09-15
10865382000218SecurAcath4F4001402016-09-15
10865382000225SecurAcath5F4001102016-09-15
10865382000232SecurAcath6F4001502016-09-15
10865382000249SecurAcath7F4001202016-09-15
10865382000256SecurAcath8F4001602016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
08800125000006SDFIXDFIXKMK2023-01-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
00618125135455Grip-LokTIDI PRODUCTS, LLCKMK2022-10-21
00618125135110Grip-LokTIDI PRODUCTS, LLCKMK2022-10-18
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3R0031C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S900C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9150C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S920C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9220C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S930C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S940C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S950C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S970C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08