Nitrex
GW N352601 Nitrex V03
10manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| 510(k) | K040345 |
| Record published | 2015-10-23 |
| Record revised | 2024-05-03 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry |
| Packaging | Pack of 3 |
| Sizes | Length 60 to 400 cm; outer diameter 0.014 to 0.035 in; outer diameter 0.89 mm; outer diameter 0.089 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N351453 | Length 145 cm | In distribution |
| N180601 | Length 60 cm | In distribution |
| N351452 | Outer Diameter.035 in | In distribution |
| N352604 | Length 260 cm | In distribution |
| N352601 | Length 260 cm | In distribution |
| N351454 | Length 145 cm | In distribution |
| N183002 | Length 300 cm | In distribution |
| N183001 | Length 300 cm | In distribution |
| N251802 | Length 180 cm | In distribution |
| N251802 | Outer Diameter.025 in | In distribution |
| N353001 | Outer Diameter.035 in | In distribution |
| N143001 | Outer Diameter.014 in | In distribution |
| N140801 | Length 80 cm | In distribution |
| N181806 | Length 180 cm | In distribution |
| N181805 | Outer Diameter.018 in | In distribution |
| N350801 | Outer Diameter.035 in | In distribution |
| N252601 | Outer Diameter.025 in | In distribution |
| N351451 | Length 145 cm | In distribution |
| N180603 | Length 60 cm | In distribution |
| N354001 | Length 400 cm | In distribution |
| N352602 | Length 260 cm | In distribution |
| N141802 | Length 180 cm | In distribution |
| N351455 | Length 145 cm | In distribution |
| N352602 | Length 260 cm | In distribution |
| N251801 | Outer Diameter.025 in | In distribution |
| N180603 | Length 60 cm | In distribution |
| N183002 | Outer Diameter.018 in | In distribution |
| N354002 | Length 400 cm | In distribution |
| N351803 | Length 180 cm | In distribution |
| N141802 | Length 180 cm | In distribution |
| N180801 | Length 80 cm | In distribution |
| N351805 | Length 180 cm | In distribution |
| N351455 | Length 145 cm | In distribution |
| N351805 | Length 180 cm | In distribution |
| N350801 | Length 80 cm | In distribution |
| N351804 | Length 180 cm | In distribution |
| N180802 | Length 80 cm | In distribution |
| N143001 | Length 300 cm | In distribution |
| N251801 | Length 180 cm | In distribution |
| N351452 | Length 145 cm | In distribution |
| N183001 | Length 300 cm | In distribution |
| N180601 | Outer Diameter.018 in | In distribution |
| N351453 | Length 145 cm | In distribution |
| N354001 | Length 400 cm | In distribution |
| N180801 | Length 80 cm | In distribution |
| N351454 | Outer Diameter.035 in | In distribution |
| N354002 | Outer Diameter.035 in | In distribution |
| N351451 | Length 145 cm | In distribution |
| N252601 | Length 260 cm | In distribution |
| N181805 | Length 180 cm | In distribution |
| N351804 | Length 180 cm | In distribution |
| N352604 | Length 260 cm | In distribution |
| N181806 | Outer Diameter.018 in | In distribution |
| N352601 | Outer Diameter.035 in | In distribution |
| N181804 | Length 180 cm | In distribution |
| N180802 | Length 80 cm | In distribution |
| N352603 | Outer Diameter.035 in | In distribution |
| N351803 | Length 180 cm | In distribution |
| N140801 | Length 80 cm | In distribution |
| N353001 | Length 300 cm | In distribution |
| N352603 | Length 260 cm | In distribution |
| N181804 | Length 180 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
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.