AccessGUDID - DEVICE: INTRAN (H671IUP7500)

GUDID

Device Identifier (DI) Information

Brand Name: INTRAN
Version or Model: Plus
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IUP-750
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671IUP7500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Disposable Intrauterine Pressure Catheter System, Amnioinfusion Capability with View Port, Zeroing Switch in Reusable Cable, Small Size Tip

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?
16431	Intrapartum pressure monitoring catheter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFN	Transducer, Pressure, Intrauterine
KXO	Monitor, Pressure, Intrauterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: Small Tip (0.19" H x 0.25" W x 0.90" L)

Device Record Status

Public Device Record Key: 391349ff-f02c-4ffc-93bd-d19e50e16ca2
Public Version Date: December 18, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016