AccessGUDID - DEVICE: CVX-RIPE (H671CVX1000)

GUDID

Device Identifier (DI) Information

Brand Name: CVX-RIPE
Version or Model: CVX-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CVX-100
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671CVX1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Double-balloon cervical dilatation catheter for cervical ripening

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47126	Cervical dilatation catheter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFJ	Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143424	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3d8b4bf-dbc7-4046-a239-3ec2424551d0
Public Version Date: December 17, 2018
Public Version Number: 1
DI Record Publish Date: November 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H671CVX1001	10	H671CVX1000		In Commercial Distribution	box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 801-566-1200
Email: customer@utahmed.com

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