FDA.reportPublic FDA data

Tru-Fix Catheter Fixation Kit

Primary DI
H862TFDR0
Brand
Tru-Fix Catheter Fixation Kit
Company
URESIL, LLC
Model
TFD-R
Catalog number
TFD-R
Device description
Tru-Fix Fixation Dressing Replacement
Published
2016-08-31
Public version status
Update
Distribution status
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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862TFDR1PackageHIBCC20Not in Commercial Distribution
H862TFDR2PackageHIBCC5In Commercial Distribution
H862TFDR0PrimaryHIBCC0

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
1-800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
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
00817640020462Thora-Vent Thoracic VentOTW11-13OTW11-132022-06-02
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31
H862TFK120Tru-Fix Catheter Fixation KitTFK-12TFK-122016-08-31
H862TFK140Tru-Fix Catheter Fixation KitTFK-14TFK-142016-08-31
H862TFK160Tru-Fix Catheter Fixation KitTFK-16TFK-162016-08-31
H862TVST0Thora-Vent Thoracic VentTVSTTVST2016-09-07
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
00817640020639Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
00817640020646Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
00817640020653Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12
00817640020660Tru-Fix Catheter Fixation KitTFK-10TFK-102022-05-12
00817640020677Tru-Fix Catheter Fixation KitTFK-12TFK-122022-05-12
00817640020684Tru-Fix Catheter Fixation KitTFK-14TFK-142022-05-12
00817640020691Tru-Fix Catheter Fixation KitTFK-16TFK-162022-05-12
H862DFALL0Aspiration and Flush AssemblyDFA-LLDFA-LL2016-08-29
H862TV11100Thora-Vent Thoracic VentTV11-10TV11-102016-09-07
H862TV11130Thora-Vent Thoracic VentTV11-13TV11-132016-09-07
H862TV13100Thora-Vent Thoracic VentTV13-10TV13-102016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22