FDA.reportPublic FDA data

CVX-RIPE

Primary DI
H671CVX1000
Brand
CVX-RIPE
Company
UTAH MEDICAL PRODUCTS, INC.
Model
CVX-100
Catalog number
CVX-100
Device description
Double-balloon cervical dilatation catheter for cervical ripening
Published
2018-11-16
Public version status
New
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
PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To LaborObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143424000UTAH CVX-RIPEUtah Medical Products, Inc.2015-08-28PFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671CVX1001PackageHIBCC10In Commercial Distribution
H671CVX1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cervical dilatation catheterA flexible, tube-like device, typically with two or more inflatable balloons at the distal working end, designed to dilate (stretch open) the cervical canal after insertion through the cervical os and expansion of the balloons to assist in obstetrical or gynaecological procedures. It may be used for labour induction, spontaneously occurring labour, non-progressive labour, cervical dystocia, undesirable prolonged uterine contractions, and intrauterine foetal death (IUFD) where delivery of the foetus is difficult. Such procedures may be performed at or prior to full-term pregnancy. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
801-566-1200customer@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
00888937027860DuoRipeCoopersurgical, Inc.PFJ2025-12-01
00888937027877DuoRipeCoopersurgical, Inc.PFJ2025-12-01
20888937027864DuoRipeCoopersurgical, Inc.PFJ2025-12-01
20888937027871DuoRipeCoopersurgical, Inc.PFJ2025-12-01
H671CVX1001CVX-RIPEUTAH MEDICAL PRODUCTS, INC.PFJ2018-11-16
00827002198913CookCOOK INCORPORATEDPFJ2016-09-24
00827002481497CookCOOK INCORPORATEDPFJ2016-09-24
10827002198910CookCOOK INCORPORATEDPFJ2016-09-24
10827002481494CookCOOK INCORPORATEDPFJ2016-09-24