FDA.reportPublic FDA data

PICC-NATE

Primary DI
H671PEEL20
Brand
PICC-NATE
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Introducer
Catalog number
PEEL2
Device description
Peel-Away Introducer, 1.9 French
Published
2016-09-24
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
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001874000PERIPHERALLY INSERTED CENTRAL CATHETERUtah Medical Products, Inc.2000-09-25LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671PEEL20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
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
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
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
H965458160BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H965458560BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H96560M13031150BioFloNAVILYST MEDICAL, INC.LJS2021-06-24
H96560M13031130BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M13031160BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M0411560BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M13031110BioFloNAVILYST MEDICAL, INC.LJS2021-03-19
H954PKM033511S0BioFloNAVILYST MEDICAL, INC.LJS2021-03-08