Laborie
Catalogue number DIS130, listed by ICU Medical, Inc, United States, under Device, Cystometric, Hydraulic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-06-08 |
| Record revised | 2025-04-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DIS130 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Air-Charged Reusable Cable | Laborie Medical Technologies, Canada ULC | 63 |
| Mediplus | Mediplus Ltd. | 45 |
| UniTip Catheter | Unisensor AG | 45 |
| Atmos Air-Charged Pressure Sensor | Medkonsult Medical Technology S.R.O. | 24 |
| Porges Coloplast | Coloplast A/S | 13 |
| Abviser | Convatec, Purchasing Department | 9 |
| NXT | Laborie Medical Technologies Corp. | 7 |
| Pump Tube Set | Laborie Medical Technologies, Canada ULC | 7 |
| Cystometry Pack | Laborie Medical Technologies, Canada ULC | 7 |
| Lumax TS Pro | Coopersurgical, Inc. | 6 |
| Bard® Urodynamic Catheter, Triple Lumen | C.R. Bard, Inc. | 6 |
| e∙Sense | Pendracare International B.V. | 5 |
Showing 12 of 238. All products under Device, Cystometric, Hydraulic
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-10-04 | Not classified | Other | Mislabeling: Product labeled with incorrect “Use Before” date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041 | 2,625 units | 2007-05-18 |
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.