FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRAN
DI: H671IUP6500
·
Model: Plus
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRAN
- Primary DI
- H671IUP6500
- Version / Model
- Plus
- Catalog Number
- IUP-650
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 13895cbc-eab0-41a4-b2b9-e2a0c841fa89
Device Description
Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Reusable Cable, Small Size Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFN | Transducer, Pressure, Intrauterine | Obstetrics/Gynecology | 884.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671IUP6501 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | H671IUP6500 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955443 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Small Tip (0.19" H x 0.25" W x 0.90" L) |