FDA.reportPublic FDA data

INTRAN

Primary DI
H671IUP6500
Brand
INTRAN
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Plus
Catalog number
IUP-650
Device description
Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Reusable Cable, Small 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

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
H671IUP6501PackageHIBCC10In Commercial Distribution
H671IUP6500PrimaryHIBCC0

Device Sizes#

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

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
H671IUP6000INTRANUTAH 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
00814247020178Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020154Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
20814247020172Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020192Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020208Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020215Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020222Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020239Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01