| Primary Device ID | 30817120021416 |
| NIH Device Record Key | d12c094f-5c42-423f-8175-902ff565ce42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio Protech |
| Version Model Number | 3838FCBZ |
| Company DUNS | 789127011 |
| Company Name | BIO PROTECH USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com | |
| Phone | 714-730-9950 |
| bioprotechusa@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817120021415 [Primary] |
| GS1 | 10817120021412 [Package] Contains: 00817120021415 Package: Poly Bag [10 Units] In Commercial Distribution |
| GS1 | 20817120021419 [Package] Contains: 10817120021412 Package: Inner Box [10 Units] In Commercial Distribution |
| GS1 | 30817120021416 [Package] Contains: 20817120021419 Package: Master Case [5 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-18 |
| 30817120021416 | 3838FCBZ - 38x38mm Electrodes, Foam, Carbon, Plastic Zip Lock - 4 pcs per pack / Tens Electrode |
| 30817120021409 | HiDow Rectangular Shape Tens Electrodes (2x3in BP Gel)- 2 pcs per pack/pouch, Multi use self-ad |
| 30817120021393 | HiDow Palm Shape Tens Electrodes (2x3in Blue Gel) - 2 pcs per pack/pouch, Multi use self-adhesiv |
| 30817120021386 | HiDow Palm Shape Tens Electrodes (2x3in BP Gel) - 2 pcs per pack/pouch, Multi use self-adhesive |
| 30817120021379 | 4141WCBZ (ECO)- Econotens, 30mil gel, 41x41mm Square Electrode, White Fabric, Carbon, Plastic Zi |
| 10817120021368 | RMC80 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 80cm length, 1.5mm (DIN 42 802) |
| 10817120021351 | RCC200 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 2m length, 5 Pole DIN, 1 per p |
| 20817120021341 | BCS-15 (Lifelines) - Lifelines OEM, Corkscrew needle, 150cm wire length, 1.5mm female TP connect |
| 20817120021334 | BE1227P-15T (Lifelines) - Lifelines OEM, Twisted EP Needle, Pairs - 150cm Leadwire, 12mm length, |
| 20817120021327 | BE1227P-25 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 250cm |
| 20817120021310 | BE1227P-20 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 200cm |
| 20817120021303 | BE1227P-15 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 150cm |
| 20817120021297 | BE1227P-10 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 100cm |
| 20817120021280 | BE1227P-05 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 50cm |
| 30817120021270 | 4141WCBZGN (ECO)- Econotens, 30mil gel, 41x41mm Square Electrode, White Fabric, Carbon, Plastic |
| 20817120021266 | RSEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fibe |
| 20817120021259 | RSEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fibe |
| 20817120021242 | RSEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fibe |
| 20817120021235 | RSEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fibe |
| 20817120021228 | RSEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fibe |
| 20817120021211 | RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fibe |
| 20817120021204 | RGEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fibe |
| 20817120021198 | RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fibe |
| 20817120021181 | RGEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fibe |
| 20817120021174 | RGEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fibe |
| 20817120021167 | DEEG-A-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Cooper Fiber + PVC Sheat |
| 20817120021150 | DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheat |
| 20817120021143 | DEEG-A-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Cooper Fiber + PVC Sheat |
| 20817120021136 | DEEG-A-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Cooper Fiber + PVC Sheat |
| 00817120021125 | MF2409 (Lifelines) - Lifelines OEM, Surface Electrodes, Ring Electrode, PET Film Backing Materia |
| 00817120021118 | NCS-SG15 (Lifelines) - Lifelines OEM, Surface Electrodes, Trio Electrode, Round Shape, Cloth Ba |
| 00817120021101 | NCS-1334 (Lifelines) - Lifelines OEM, Surface Electrodes, NCS Surface Electrode, Tabs, PET Film |
| 00817120021095 | SG15G (Lifelines) - Lifelines OEM, Surface Electrodes, Square Shape, Ground Electrode, Cloth Bac |
| 20817120021082 | SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel |
| 10817120021078 | RNC100 (Lifelines) - Lifelines OEM, Cables for Surface Electrodes, 1.5m length, 1.5mm (DIN 42 80 |
| 10817120021061 | RMC100 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 1m length, 1.5mm (DIN 42 802), |
| 10817120021054 | RCC100 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 1m length, 5 Pole DIN, 1 per p |
| 20817120021044 | BH7523P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 75mm length, 0.65mm(23G) Diam |
| 20817120021037 | BH5026P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 50mm length, 0.45mm(26G) Diam |
| 20817120021020 | BH3726P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 37mm length, 0.45mm(26G) Diam |
| 20817120021013 | BH3727P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 37mm length, 0.40mm(27G) Diam |
| 20817120021006 | BH2527P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 25mm length, 0.40mm(27G) Diam |
| 20817120020993 | BH2530P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 25mm length, 0.30mm(30G) Diam |
| 20817120020986 | BM7526P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 75mm length, 0.45mm (26G) Diame |
| 20817120020979 | BM7526 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 75mm length, 0.45mm (26G) Diamet |
| 20817120020962 | BM5026P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 50mm length, 0.45mm (26G) Diame |
| 20817120020955 | BM5026(Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 50mm length, 0.45mm (26G) Diamete |
| 20817120020948 | BM3726P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 37mm length, 0.45mm (26G) Diame |
| 20817120020931 | BM3726 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 37mm length, 0.45mm (26G) Diamet |
| 20817120020924 | BM3728P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 37mm length, 0.36mm (28G) Diame |