Bio Protech
NDRH: Monopolar single use pencil, rocker switch; holster; needle electrode; L 3 m (1 pc per pack, 20 packs in a inner box, 40 packs in a master case)
4manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | BIO Protech USA, Inc. |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Record published | 2017-08-09 |
| Record revised | 2018-06-13 (version 4) |
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, manufacturing date, serial number |
| Packaging | Inner box of 25, master case of 8, master case of 2, inner box of 20, master case of 20, inner box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC5026 (Lifelines) | In distribution | |
| BE1227P-20 (Lifelines) | In distribution | |
| BM2526 (Lifelines) | In distribution | |
| BM3726 (Lifelines) | In distribution | |
| DR | In distribution | |
| DB | In distribution | |
| BM7526P (Lifelines) | In distribution | |
| BC2530 (Lifelines) | In distribution | |
| DR-5 | In distribution | |
| NDRH | In distribution | |
| BM2528P (Lifelines) | In distribution | |
| BM5026 (Lifelines) | In distribution | |
| BCS-15 (Lifelines) | In distribution | |
| BH2530P (Lifelines) | In distribution | |
| BH3726P (Lifelines) | In distribution | |
| BH5026P (Lifelines) | In distribution | |
| BE1227P-10 (Lifelines) | In distribution | |
| BE1227P-15T (Lifelines) | In distribution | |
| NDBH | In distribution | |
| BC7523 (Lifelines) | In distribution | |
| BM3728P (Lifelines) | In distribution | |
| BC3826 (Lifelines) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
Showing 12 of 106. All products under Electrode, Needle
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.