Unipower
623 catalogue numbers from B11266, listed by Unipower Corp., United States, under Dc-Defibrillator, Low-Energy, (Including Paddles). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
623catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Unipower Corp., United States |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Establishment | Manufacturer |
| 510(k) | K940842 |
| Record published | 2016-09-15 |
| Record revised | 2023-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2017-01-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B11266 | In distribution | |
| B11933 | In distribution | |
| B12028 | In distribution | |
| B12037 | In distribution | |
| B11533 | In distribution | |
| B11548 | In distribution | |
| B11552 | In distribution | |
| B12306 | In distribution | |
| B12089 | In distribution | |
| B11961 | In distribution | |
| B11113 | In distribution | |
| B11193 | In distribution | |
| B11435 | In distribution | |
| B00925 | In distribution | |
| B11325 | In distribution | |
| B12253 | In distribution | |
| B11227 | In distribution | |
| B10634 | In distribution | |
| B10027 | In distribution | |
| B11426 | In distribution | |
| B11044 | In distribution | |
| B11851 | In distribution | |
| B11128 | In distribution | |
| B11844 | In distribution | |
| B11758 | In distribution | |
| B12243 | In distribution | |
| B11274 | In distribution | |
| B11734 | In distribution | |
| B12096 | In distribution | |
| B12075 | In distribution | |
| B11577 | In distribution | |
| B11980 | In distribution | |
| B10725 | In distribution | |
| B11549 | In distribution | |
| B11927 | In distribution | |
| B10908 | In distribution | |
| B12077 | In distribution | |
| B11893 | In distribution | |
| B12086 | In distribution | |
| B10704 | In distribution | |
| B10979 | In distribution | |
| B11506 | In distribution | |
| B11641 | In distribution | |
| B10966 | In distribution | |
| B11745 | In distribution | |
| B11403 | In distribution | |
| B10097 | In distribution | |
| B11104 | In distribution | |
| B10728 | In distribution | |
| B11418 | In distribution | |
| B11848 | In distribution | |
| B11337 | In distribution | |
| B11469 | In distribution | |
| B10576 | In distribution | |
| B11080 | In distribution | |
| B11649 | In distribution | |
| B11471 | In distribution | |
| B11957 | In distribution | |
| B11687 | In distribution | |
| B11939 | In distribution | |
| B11310 | In distribution | |
| B12258 | In distribution | |
| B11853 | In distribution | |
| B12015 | In distribution | |
| B11215 | In distribution | |
| B12031 | In distribution | |
| B12256 | In distribution | |
| B10186 | In distribution | |
| B12088 | In distribution | |
| B11678 | In distribution | |
| B11956 | In distribution | |
| B10340 | In distribution | |
| B10729 | In distribution | |
| B11899 | In distribution | |
| B11659 | In distribution | |
| B11384 | In distribution | |
| B11484 | In distribution | |
| B11495 | In distribution | |
| B11839 | In distribution | |
| B10827 | In distribution | |
| B12062 | In distribution | |
| B12080 | In distribution | |
| B11052 | In distribution | |
| B10747 | In distribution | |
| B10135 | In distribution | |
| B11117 | In distribution | |
| B11602 | In distribution | |
| B11998 | In distribution | |
| B11256 | In distribution | |
| B11454 | In distribution | |
| B10167 | In distribution | |
| B11329 | In distribution | |
| B10806 | In distribution | |
| B11810 | In distribution | |
| B11305 | In distribution | |
| B11336 | In distribution | |
| B11670 | In distribution | |
| B11863 | In distribution | |
| B11827 | In distribution | |
| B11067 | In distribution | |
| B11658 | In distribution | |
| B11126 | In distribution | |
| B10767 | In distribution | |
| B11542 | In distribution | |
| B12047 | In distribution | |
| B11633 | In distribution | |
| B10015 | In distribution | |
| B10209 | In distribution | |
| B11978 | In distribution | |
| B11770 | In distribution | |
| B11434 | In distribution | |
| B11249 | In distribution | |
| B10584 | In distribution | |
| B11254 | In distribution | |
| B10238 | In distribution | |
| B10920 | In distribution | |
| B11509 | In distribution | |
| B11617 | In distribution | |
| B11490 | In distribution | |
| B11431 | In distribution | |
| B11744 | In distribution | |
| B12003 | In distribution | |
| B11459 | In distribution | |
| B11417 | In distribution | |
| B11102 | In distribution | |
| B11535 | In distribution | |
| B12017 | In distribution | |
| B11765 | In distribution | |
| B11464 | In distribution | |
| B11995 | In distribution | |
| B10796 | In distribution | |
| B12095 | In distribution | |
| B11374 | In distribution | |
| B11321 | In distribution | |
| B12016 | In distribution | |
| B12246 | In distribution | |
| B11559 | In distribution | |
| B11207 | In distribution | |
| B12065 | In distribution | |
| B11516 | In distribution | |
| B11794 | In distribution | |
| B11776 | In distribution | |
| B12076 | In distribution | |
| B11664 | In distribution | |
| B11981 | In distribution | |
| B10001 | In distribution | |
| B11708 | In distribution | |
| B11583 | In distribution | |
| B10412 | In distribution | |
| B11953 | In distribution | |
| B12252 | In distribution | |
| B11413 | In distribution | |
| B11225 | In distribution | |
| B12005 | In distribution | |
| B11703 | In distribution | |
| B11370 | In distribution | |
| B12046 | In distribution | |
| B11783 | In distribution | |
| B11178 | In distribution | |
| B10570 | In distribution | |
| B11943 | In distribution | |
| B11397 | In distribution | |
| B11409 | In distribution | |
| B11150 | In distribution | |
| B11401 | In distribution | |
| B11204 | In distribution | |
| B11775 | In distribution | |
| B10230 | In distribution | |
| B11036 | In distribution | |
| B10998 | In distribution | |
| B11802 | In distribution | |
| B11626 | In distribution | |
| B11378 | In distribution | |
| B11654 | In distribution | |
| B11719 | In distribution | |
| B12059 | In distribution | |
| B12055 | In distribution | |
| B10834 | In distribution | |
| B11586 | In distribution | |
| B11407 | In distribution | |
| B11847 | In distribution | |
| B11525 | In distribution | |
| B10765 | In distribution | |
| B11932 | In distribution | |
| B11171 | In distribution | |
| B12092 | In distribution | |
| B11242 | In distribution | |
| B11229 | In distribution | |
| B10683 | In distribution | |
| B11922 | In distribution | |
| B11477 | In distribution | |
| B11520 | In distribution | |
| B11443 | In distribution | |
| B11377 | In distribution | |
| B11479 | In distribution | |
| B11423 | In distribution | |
| B11737 | In distribution | |
| B11120 | In distribution | |
| B10426 | In distribution | |
| B11571 | In distribution | |
| B11239 | In distribution | |
| B11560 | In distribution | |
| B11869 | In distribution | |
| B12103 | In distribution | |
| B11846 | In distribution | |
| B11760 | In distribution | |
| B10994 | In distribution | |
| B11414 | In distribution | |
| B11669 | In distribution | |
| B11944 | In distribution | |
| B11718 | In distribution | |
| B11785 | In distribution | |
| B11528 | In distribution | |
| B10719 | In distribution | |
| B12068 | In distribution | |
| B11988 | In distribution | |
| B11723 | In distribution | |
| B11968 | In distribution | |
| B12005 | In distribution | |
| B10909 | In distribution | |
| B11773 | In distribution | |
| B11474 | In distribution | |
| B00867 | In distribution | |
| B11534 | In distribution | |
| B11787 | In distribution | |
| B12000 | In distribution | |
| B12102 | In distribution | |
| B11293 | In distribution | |
| B10824 | In distribution | |
| B12101 | In distribution | |
| B11908 | In distribution | |
| B10964 | In distribution | |
| B10992 | In distribution | |
| B11900 | In distribution | |
| B11778 | In distribution | |
| B11990 | In distribution | |
| B10198 | In distribution | |
| B11272 | In distribution | |
| B11270 | In distribution | |
| B11450 | In distribution | |
| B11814 | In distribution | |
| B11652 | In distribution | |
| B11648 | In distribution | |
| B11496 | In distribution | |
| B10795 | In distribution | |
| B11813 | In distribution | |
| B11614 | In distribution | |
| B11333 | In distribution | |
| B12066 | In distribution | |
| B11743 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Internal Handle | Zoll Medical Corporation | 89 |
| Vermed | Nissha Medical Technologies Limited | 47 |
| Cardio Clear | Cardio Medical Products, Inc. | 33 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Fiab SPA | 20 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Physio-Control, Inc. | 20 |
| R2 | ConMed Corporation | 17 |
| HeartStart | Philips Medical Systems Hsg | 9 |
| Anybattery | Anybattery, Inc | 6 |
| Tempus LS-Manual | Remote Diagnostic Technologies Ltd. | 6 |
| Vermed Defib Pads | Graphic Controls Acquisition Corporation | 5 |
| HeartStart | Philips Electronics North America Corporation | 4 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940842 | 1994-09-07 |
| K935111 | 1994-03-28 |
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.