Portex
45 catalogue numbers from 8520BMF, listed by ICU Medical, Inc, United States, under Ventilator, Emergency, Manual (Resuscitator). 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K884526 |
| Record published | 2018-07-20 |
| Record revised | 2025-04-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature -40 to 60 °C |
| Packaging | Box of 12, box of 9, case of 9, case of 12, box of 10 |
| Distribution end date | 2019-09-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8520BMF | In distribution | |
| 8500BMP | In distribution | |
| 8500C | In distribution | |
| 8502 | In distribution | |
| 8503C | In distribution | |
| 8506P | In distribution | |
| 8505 | In distribution | |
| 8501 | In distribution | |
| 8529MM | In distribution | |
| 8528MM | In distribution | |
| 8520 | In distribution | |
| 8515AB | In distribution | |
| 8520BM | In distribution | |
| 8506F | In distribution | |
| 8515C | In distribution | |
| 8506 | In distribution | |
| 8529MB | In distribution | |
| 8508 | In distribution | |
| 8503F | In distribution | |
| 8527MP | In distribution | |
| 8500P | In distribution | |
| 8500BM | In distribution | |
| 8529BMF | In distribution | |
| 8520BMP | In distribution | |
| 8529M | In distribution | |
| 8515A | In distribution | |
| 8506C | In distribution | |
| 8529BM | In distribution | |
| 8515PB | In distribution | |
| 8503P | In distribution | |
| 8515P | In distribution | |
| 8520B | In distribution | |
| 8500BMF | In distribution | |
| 8500 | In distribution | |
| 8528BMP | In distribution | |
| 8528BM | In distribution | |
| 8500F | In distribution | |
| 8528M | In distribution | |
| 8528MB | In distribution | |
| 8528BMF | In distribution | |
| 8503 | In distribution | |
| 8527MPB | In distribution | |
| 8529BMP | In distribution | |
| 008050 | Withdrawn | |
| 008012 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
| Vital Signs | Carefusion | 31 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Sims Portex, Inc. | 510(k) number | 2002-11-15 | Not classified | Other | Peep valve set at the highest level and could result in patient injury | 1188 units | 2004-05-11 |
| Sims Portex, Inc. | 510(k) number | 2002-11-15 | Not classified | Other | Peep valve set at the highest level and could result in patient injury | 2976 | 2004-05-11 |
| Sims Portex, Inc. | 510(k) number | 2002-11-15 | Not classified | Other | Peep valve set at the highest level and could result in patient injury | 6252 units | 2004-05-11 |
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.