FDA.reportPublic FDA data

Tru-Fix Catheter Fixation Kit

Primary DI
00817640020653
Brand
Tru-Fix Catheter Fixation Kit
Company
URESIL, LLC
Model
TFK-08
Catalog number
TFK-08
Device description
Tru-Fix Catheter Fixation Kit - 8F
Published
2022-05-12
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
10817640020650PackageGS15In Commercial Distribution
20817640020657PackageGS15In Commercial Distribution
H862TFK080PreviousHIBCC0
00817640020653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081764002065010817640020650
2081764002065720817640020657
00817640020653008176400206538176400206530817640020653

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 Gauge8French

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
00817640020165Nephro-Stent Nephroureteral Stent CatheterNSL2T-0822HNSL2T-0822H2022-04-28
00817640020172Nephro-Stent Nephroureteral Stent CatheterNSL2T-0824HNSL2T-0824H2022-04-28
00817640020189Nephro-Stent Nephroureteral Stent CatheterNSL2T-0826HNSL2T-0826H2022-04-28
00817640020196Nephro-Stent Nephroureteral Stent CatheterNSL2T-0828HNSL2T-0828H2022-04-28
00817640020516Nephro-Stent Nephroureteral Stent CatheterNSL2T-1022HNSL2T-1022H2022-04-28
00817640020523Nephro-Stent Nephroureteral Stent CatheterNSL2T-1024HNSL2T-1024H2022-04-28
00817640020530Nephro-Stent Nephroureteral Stent CatheterNSL2T-1026HNSL2T-1026H2022-04-28
00817640020547Nephro-Stent Nephroureteral Stent CatheterNSL2T-1028HNSL2T-1028H2022-04-28
00817640020387Nephro-Stent Nephroureteral Stent CatheterNSL2-0822HNSL2-0822H2022-04-29
00817640020394Nephro-Stent Nephroureteral Stent CatheterNSL2-0824HNSL2-0824H2022-04-29
00817640020400Nephro-Stent Nephroureteral Stent CatheterNSL2-0826HNSL2-0826H2022-04-29
00817640020417Nephro-Stent Nephroureteral Stent CatheterNSL2-0828HNSL2-0828H2022-04-29
00817640020424Nephro-Stent Nephroureteral Stent CatheterNSL2-1022HNSL2-1022H2022-04-29
00817640020431Nephro-Stent Nephroureteral Stent CatheterNSL2-1024HNSL2-1024H2022-04-29
00817640020448Nephro-Stent Nephroureteral Stent CatheterNSL2-1026HNSL2-1026H2022-04-29
00817640020455Nephro-Stent Nephroureteral Stent CatheterNSL2-1028HNSL2-1028H2022-04-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17