Intran
Disposable Intrauterine Pressure Catheter System, Amnioinfusion Capability with View Port, Zeroing Switch in Disposable Catheter, Regular Size Tip
2manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | HFN |
| Device type | Transducer, Pressure, Intrauterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K955443 |
| Record published | 2016-09-23 |
| Record revised | 2026-03-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Plus | Small Tip (0.19″ H x 0.25″ W x 0.90″ L) | In distribution |
| Plus | Small Tip (0.19″ H x 0.25″ W x 0.90″ L) | In distribution |
| Plus | Small Tip (0.19″ H x 0.25″ W x 0.90″ L) | In distribution |
| Plus | Regular Tip (0.25″ H x 0.30″ W x 1.00″ L) | In distribution |
| Plus | Regular Tip (0.25″ H x 0.30″ W x 1.00″ L) | In distribution |
| Plus | Regular Tip (0.25″ H x 0.30″ W x 1.00″ L) | In distribution |
| Plus | Regular Tip (0.25″ H x 0.30″ W x 1.00″ L) | In distribution |
| Plus | Small Tip (0.19″ H x 0.25″ W x 0.90″ L) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Koala® Cables | Clinical Innovations, LLC | 9 |
| Koala® | Clinical Innovations, LLC | 2 |
| Advanced Fetal Monitor | Advanced Instrumentations, Inc. | 1 |
| Transducer, Pressure, Intrauterine | Philips Medizin Systeme Böblingen GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961424 | 1996-07-10 |
| K955443 | 1996-02-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Utah Medical Products, Inc. | 510(k) number | 2008-06-16 | Not classified | Component change control | Possibility of compromised package sterility prior to the expiration date. | 300,000 units. | 2011-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.