Intran Plus Intrauterine Pressure Monitor
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- INTRAN EUDAMEDFDA UDIN/A FDA UDI
- Generic Name
- Intrapartum pressure monitoring catheter FDA UDI
- Device Name
- Intran EUDAMEDDisposable Intrauterine Pressure Catheter System, Amnioinfusion Capability with View Port, Zeroing Switch in Reusable Cable, Regular Size Tip FDA UDIDisposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Disposable Catheter, Small Size Tip FDA UDIIntrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter / Transducer, 78" Lumen, with 20cc Syringe FDA UDI
- Model / Reference
- IUP-075 EUDAMEDIUP-450 EUDAMEDIUP-700 EUDAMEDPlus FDA UDIN/A FDA UDI
- Description
- Disposable Intrauterine Pressure Catheter System, Amnioinfusion Capability with View Port, Zeroing Switch in Reusable Cable, Regular Size Tip FDA UDIDisposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Disposable Catheter, Small Size Tip FDA UDIIntrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter / Transducer, 78" Lumen, with 20cc Syringe FDA UDI
Identifiers
- Catalog Number
- IUP-700 FDA UDIIUP-450 FDA UDIIUP-075 FDA UDI
- Primary DI / UDI-DI
- H671IUP7000 EUDAMEDFDA UDIH671IUP4500 EUDAMEDFDA UDIH671IUP0750 EUDAMEDFDA UDI
- Basic UDI-DI
- ++H671CE005IIACE EUDAMED
- FDA Product Code
- KXO FDA 510(k)FDA UDIHFN FDA UDI
- EMDN Code
- U100199 OBSTETRICAL CATHETERS - OTHER EUDAMED
- GMDN Term
- Intrapartum pressure monitoring catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.2700 FDA 510(k)
- Regulation Number
- 884.2700 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 78 Inch FDA UDI
The Intran Plus is an Intrauterine Pressure Monitor (Device Class II), designed to measure and display real-time intrauterine pressure during labor and delivery. It provides continuous monitoring to assess uterine contractions, fetal well-being, and labor progression, supporting clinical decision-making in obstetric care.
This device is supplied as a reusable system, intended for use in hospital labor and delivery units. It is not sterile at shipment and requires sterilization before first use, adhering to standard medical device reprocessing protocols. The Intran Plus is MRI-safe for use in non-magnetic imaging environments and is authorized under FDA 510(k) clearance (K905563) and EU MDR compliance. Multiple registration numbers (e.g., 9681860, 1423537) reflect its regulatory filing status in the U.S.
Frequently asked questions
How is the Intran Plus system prepared for use in a clinical setting, and what sterilization methods are recommended before first use?
The Intran Plus is supplied as a reusable system and is not sterile at shipment, requiring sterilization before its first use. It must be processed following standard medical device reprocessing protocols to ensure safety and functionality. The manufacturer does not specify particular sterilization methods in the provided data, so hospitals should follow their established infection control policies for reusable medical devices.
Is the Intran Plus compatible with MRI environments, and if so, under what conditions?
Yes, the Intran Plus is MRI-safe for use in non-magnetic imaging environments. This means it can be used in hospital settings where MRI scans are performed, provided the imaging equipment is not generating strong magnetic fields that could interfere with the device’s operation. Always verify compatibility with your specific MRI system before use.
What types of clinical environments is the Intran Plus intended for, and how is it typically deployed?
The Intran Plus is designed for hospital labor and delivery units, where it is used to monitor intrauterine pressure during labor and delivery. It is supplied as a reusable system, meaning it is meant to be used repeatedly across multiple patients after proper sterilization and reprocessing. Its primary purpose is to provide real-time data on uterine contractions, fetal well-being, and labor progression to aid clinical decision-making.
What regulatory pathways has the Intran Plus followed, and how does this affect its use in the U.S. and Europe?
The Intran Plus has undergone FDA 510(k) clearance (K905563) and is compliant with the EU Medical Device Regulation (MDR). In the U.S., its clearance under the 510(k) pathway means it is considered substantially equivalent to a predicate device and is authorized for use in obstetrics/gynecology settings. In Europe, its MDR compliance ensures it meets safety, performance, and regulatory requirements for clinical use within the EU market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K905563 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (7)
- FDA 510(k) K905563 24 fields · synced Oct 6, 2026
- FDA UDI cedbf0d8-0d9c-4212-a0e6-11c61cd992dc 36 fields · synced May 29, 2026
- FDA UDI 87675444-fca9-4eb7-a4d0-587f7d85f40c 36 fields · synced May 30, 2026
- FDA UDI afeb250a-651d-429a-b95b-84c80ac5d840 37 fields · synced May 30, 2026
- EUDAMED 5601d0a7-5303-43f8-b538-48adb52e47fc 61 fields · synced Jul 15, 2026
- EUDAMED 1604ca14-abcb-43b1-ab1f-fa4b9ef2ee41 61 fields · synced Aug 2, 2026
- EUDAMED 4946e7c1-b025-41c7-8eab-76f591a2b3fa 61 fields · synced Aug 4, 2026