Portex
33 catalogue numbers from C45091463D-NL, listed by ICU Medical, Inc, United States, under Mask, Gas, Anesthetic. 71 manufacturers in China are registered for this product code.
71manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (27), Guangdong (16), Jiangsu (8). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 71. All 71 manufacturers in China registered for Mask, Gas, Anesthetic
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BSJ |
| Device type | Mask, Gas, Anesthetic |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-07 |
| 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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20, carton of 15, box of 20, box of 12, bag of 20, box of 15 |
| Distribution end date | 2020-07-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C45091463D-NL | In distribution | |
| C45091315J | In distribution | |
| 225-3708-802 | In distribution | |
| 370956D-NL | In distribution | |
| 4509901D | In distribution | |
| C37091782D-NL | In distribution | |
| C45091611D-NL | In distribution | |
| 225-3719-804-NL | In distribution | |
| C1123 | In distribution | |
| C37091426-NL | In distribution | |
| C45091783D-NL | In distribution | |
| C45091773D-NL | In distribution | |
| VP1344 | In distribution | |
| C45091692-NL | In distribution | |
| C45091702D-NL | In distribution | |
| 370916-NL | In distribution | |
| C49091445 | In distribution | |
| C45031545D-NL | In distribution | |
| C1036J | In distribution | |
| C37091771D-NL | In distribution | |
| C45091622D-NL | In distribution | |
| 491000-NL | In distribution | |
| C45091460D-NL | In distribution | |
| 450951-NL | In distribution | |
| 370374-NL | In distribution | |
| 225-3718-800 | In distribution | |
| VP1343 | In distribution | |
| C1082 | In distribution | |
| C1087 | Withdrawn | |
| C1077 | Withdrawn | |
| 225-3710-800-NL | Withdrawn | |
| C37091632D-NL | Withdrawn | |
| 371056 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 205 |
| Medline | Medline Industries, Inc. | 49 |
| Rusch | Teleflex Medical LLC | 45 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
| AincA® | Anesthesia Associates, Inc. | 29 |
| Hudson RCI | Teleflex Medical LLC | 27 |
| Deluxe Full Face Mask | Mercury Medical Enterprises, LLC | 27 |
| King Mask | Ambu A/S | 26 |
| Mask, Gas, Anesthetic | VBM Medizintechnik Gmbh | 23 |
| Cardinal Health | Cardinal Health 200, LLC | 23 |
| Vital Signs™ | Airlife, Inc. | 19 |
| Exin | Foremount Enterprise Co., Ltd. | 19 |
Showing 12 of 270. All products under Mask, Gas, Anesthetic
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.