NGM Medex Pressure Cable, P1
Catalogue number CAB1036, listed by Laborie Medical Technologies Corp., United States, under Device, Cystometric, Hydraulic. 3 manufacturers in China are registered for this product code.
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 | Laborie Medical Technologies Corp., United States |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature -29 to 60 °C; Handling environment humidity 15 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAB1036 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K073552 | 2008-03-05 |
| K951805 | 1995-07-06 |
| K950016 | 1995-03-30 |
| K942023 | 1994-07-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-07-17 | Class II | Nonconforming Material/Component | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard | 2 US | 2023-07-10 |
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.