FDA.reportPublic FDA data

N/A

Primary DI
H671IUP0750
Brand
N/A
Company
UTAH MEDICAL PRODUCTS, INC.
Model
N/A
Catalog number
IUP-075
Device description
"Intrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter / Transducer, 78"" Lumen, with 20cc Syringe"
Published
2016-09-23
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
KXOMonitor, Pressure, Intrauterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXOMonitor, Pressure, IntrauterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862873000IUC - INTRAUTERINE CATHETERUtah Medical Products, Inc.1987-02-26KXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671IUP0751PackageHIBCC10In Commercial Distribution
H671IUP0750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intrapartum pressure monitoring catheterA flexible tube with a pressure sensor, transducer, and/or thermistor located at its distal tip, used for intrapartum transcervical measurement of the intrauterine and amniotic pressures. It is attached at its proximal end via a signal cable to an external monitor that displays the pressure/temperature values, and is used to monitor the intensity, duration, and frequency of uterine contractions during labour. It may also be used for fluid infusion and sampling of amniotic fluid. It is typically made of plastic [e.g., polyethylene, polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane] and/or silicone, and may include a catheter introducer/sheath. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Inch

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
10884521643604KendallCardinal Health, Inc.KXO2018-05-26
10884521725492KendallCardinal Health, Inc.KXO2017-05-24
20884521725499KendallCardinal Health, Inc.KXO2017-05-24
20884521164267KendallCardinal Health, Inc.KXO2016-09-24
30884527004908KendallCardinal Health, Inc.KXO2016-09-24
10884521643611KendallCardinal Health, Inc.KXO2016-09-24
10884521643628KendallCardinal Health, Inc.KXO2016-09-24
10884521164260KendallCardinal Health, Inc.KXO2016-09-24
20884527004901KendallCardinal Health, Inc.KXO2016-09-24
H671IUP0751N/AUTAH MEDICAL PRODUCTS, INC.KXO2016-09-23