FDA.reportPublic FDA data

INTRAN

Primary DI
H671IUP6000
Brand
INTRAN
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Plus
Catalog number
IUP-600
Device description
Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Reusable Cable, Regular Size Tip
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
HFNTransducer, Pressure, Intrauterine

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955443000INTRAN PLUSUtah Medical Products, Inc.1996-02-20HFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671IUP6001PackageHIBCC10In Commercial Distribution
H671IUP6000PrimaryHIBCC0

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
Device Size Text, specify0

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
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HFN2020-04-16
00884838001404NAPhilips Medizin Systeme Böblingen GmbHHFN2016-11-21
H671IUP4000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
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00814247020215Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020222Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
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