Vital Signs™
Vital Signs™ flow-inflating tail-end valve transport circuit
8manufacturers in China registered for this device type
102catalogue 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 | Airlife, Inc., United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| 510(k) | K812273 |
| Record published | 2019-12-20 |
| Record revised | 2025-04-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 20, case of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4FX20X4 | In distribution | |
| A46129X4 | In distribution | |
| 5102RVX1 | In distribution | |
| AD6X200X | In distribution | |
| GK7FXXXX | In distribution | |
| A4ZX20X4D | In distribution | |
| 5102RVW | In distribution | |
| A8ZX2044 | In distribution | |
| A8T52914 | In distribution | |
| A4F123XX | In distribution | |
| A5U560XX | In distribution | |
| 5102RV | In distribution | |
| A8ZX20X4 | In distribution | |
| A4UX6044 | In distribution | |
| A4UX20XZU | In distribution | |
| A5Z129X4 | In distribution | |
| A4FX6004 | In distribution | |
| A4Z529XX | In distribution | |
| A8ZX2844 | In distribution | |
| ADF329X4 | In distribution | |
| A5U520X4 | In distribution | |
| A4U519X4 | In distribution | |
| A4ZX2004 | In distribution | |
| A5Z329X4 | In distribution | |
| A4F12014 | In distribution | |
| A8U52044 | In distribution | |
| GBNLXXXX | In distribution | |
| A4Y580X4F | In distribution | |
| A8U529X4 | In distribution | |
| AD6529X5 | In distribution | |
| ADU320X4D | In distribution | |
| ADFX1944 | In distribution | |
| A5VX204X | In distribution | |
| A5G529X4 | In distribution | |
| ADU119XX | In distribution | |
| A5F329XX | In distribution | |
| A5U510X4 | In distribution | |
| AD1529X5 | In distribution | |
| A5Z120XX | In distribution | |
| A4FX2004 | In distribution | |
| A46517XX | In distribution | |
| A4VX2304 | In distribution | |
| A8U52015 | In distribution | |
| A4V384XX | In distribution | |
| A4FX20XXC | In distribution | |
| A4UX2441 | In distribution | |
| A4FX2005 | In distribution | |
| 5102RVX1 | In distribution | |
| 5104RDVX | In distribution | |
| 5102RCV1 | In distribution | |
| A4Y520X4F | In distribution | |
| ADU520X4D | In distribution | |
| A4U520AZ | In distribution | |
| ADUX2004 | In distribution | |
| A5U520X0 | In distribution | |
| A4FX20XZD | In distribution | |
| A5U520XX | In distribution | |
| A4ZX20X4 | In distribution | |
| A8FX804X | In distribution | |
| A8UX204X | In distribution | |
| AKUX20X4D | In distribution | |
| A8W52914 | In distribution | |
| A46X29XX | In distribution | |
| A4UX20XZT | In distribution | |
| A4F52014 | In distribution | |
| A41119X4 | In distribution | |
| A4ZX60XZU | In distribution | |
| A4UX20XZD | In distribution | |
| A4UX20X4A1 | In distribution | |
| A5U560X4 | In distribution | |
| A4U320X4 | In distribution | |
| ADW32014 | In distribution | |
| AD6529X4 | In distribution | |
| A4Z12014 | In distribution | |
| 5102RLV1 | In distribution | |
| ADF52044 | In distribution | |
| A4SXX0XZDX6 | In distribution | |
| A8UB20X4 | In distribution | |
| ADWX204X | In distribution | |
| AMY520X4F | In distribution | |
| A46X2044 | In distribution | |
| ADFX208Z | In distribution | |
| ADT520XX | In distribution | |
| A4UX204X | In distribution | |
| A5ZX7044 | In distribution | |
| A5G119X4 | In distribution | |
| ADF380X4 | In distribution | |
| 5102RCV1 | In distribution | |
| AXXXX170 | In distribution | |
| A4F119X4 | In distribution | |
| 5126DLV1 | In distribution | |
| A565203X | In distribution | |
| 5102RXV | In distribution | |
| A5U320XX | In distribution | |
| A4FX20X4D | In distribution | |
| 5102RV | In distribution | |
| A4UX200Z | In distribution | |
| AMY520X4 | In distribution | |
| 5202RADY | In distribution | |
| A4UX2044 | In distribution | |
| AXXXX131 | In distribution | |
| A4Z12024 | In distribution |
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 |
| 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 |
| Portex | ICU Medical, Inc | 45 |
| 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)
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.