FDA.reportPublic FDA data

SecurAcath

Primary DI
10865382000256
Brand
SecurAcath
Company
INTERRAD MEDICAL, INC
Model
8F
Catalog number
400160
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKCImplanted Subcutaneous Securement Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKCImplanted Subcutaneous Securement CatheterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865382000256PackageGS110In Commercial Distribution
00865382000259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086538200025610865382000256
00865382000259008653820002598653820002590865382000259

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 Gauge8French

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555472310
Device count
1
DM exempt
false
Premarket exempt
false
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
00865382000204SecurAcath3F4001302016-09-15
00865382000211SecurAcath4F4001402016-09-15
00865382000228SecurAcath5F4001102016-09-15
00865382000235SecurAcath6F4001502016-09-15
00865382000242SecurAcath7F4001202016-09-15
00865382000259SecurAcath8F4001602016-09-15
00865382000280SecurAcath12F4002002020-06-03
00865382000297SecurAcath10F4001802020-06-03
10865382000201SecurAcath3F4001302016-09-15
10865382000218SecurAcath4F4001402016-09-15
10865382000225SecurAcath5F4001102016-09-15
10865382000232SecurAcath6F4001502016-09-15
10865382000249SecurAcath7F4001202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106547625CARDINAL HEALTHCardinal Health 200, LLCOKC2024-02-26
50197106547623CARDINAL HEALTHCardinal Health 200, LLCOKC2024-02-26
10195594894368CARDINAL HEALTHCardinal Health 200, LLCOKC2022-10-19
50195594894366CARDINAL HEALTHCardinal Health 200, LLCOKC2022-10-19
00865382000280SecurAcathINTERRAD MEDICAL, INCOKC2020-06-03
00865382000297SecurAcathINTERRAD MEDICAL, INCOKC2020-06-03
00865382000204SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000211SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000228SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000235SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000242SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000259SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000201SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000218SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000232SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000249SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15