Ventlab
AirFlow Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line
8manufacturers in China registered for this device type
405catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Ventlab, LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Record published | 2023-07-12 |
| Record revised | 2024-01-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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 | Special storage condition: Store at room temperature. Do not get wet. |
| Packaging | Box of 10, case of 10, box |
| Sizes | Total volume 250 to 1900 ml; total volume 300 Microliter |
| Distribution end date | 2026-01-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AF3100MBP-2 | Total Volume 300 ml | In distribution |
| SC9101B | Total Volume 1900 ml | In distribution |
| AF1140MB-D5 | Total Volume 1900 ml | In distribution |
| AF2142MB | Total Volume 1000 ml | In distribution |
| AF1100MBS | Total Volume 1900 ml | In distribution |
| AFM3106MC-2 | Total Volume 300 ml | In distribution |
| VN2102MX | Total Volume 1000 ml | In distribution |
| AF2142MB-M5E | Total Volume 1000 ml | In distribution |
| AF3040MB | Total Volume 300 ml | In distribution |
| AF2042MBP-Z | Total Volume 1000 ml | In distribution |
| AF5000MB-I | Total Volume 1500 ml | In distribution |
| VN3100MC-D1 | Total Volume 300 ml | In distribution |
| AF1040MB-K | Total Volume 1900 ml | In distribution |
| AF1100MB-MMC | Total Volume 1900 ml | In distribution |
| VN5000MC | Total Volume 1500 ml | In distribution |
| AF1140MB-P5 | Total Volume 1900 ml | In distribution |
| AF1000MXP | Total Volume 1900 ml | In distribution |
| AF1140OB | Total Volume 1900 ml | In distribution |
| AF2100MB-MMC | Total Volume 1000 ml | In distribution |
| SS3200MB-2 | Total Volume 250 ml | In distribution |
| AF5142MB | Total Volume 1500 ml | In distribution |
| AF3140MB-2 | Total Volume 300 ml | In distribution |
| AF5143MBS-R | Total Volume 1500 ml | In distribution |
| AF1003MB | Total Volume 1900 ml | In distribution |
| SS3200MB-I | Total Volume 250 ml | In distribution |
| AF5140MB-I | Total Volume 1500 ml | In distribution |
| VN3000MB-2 | Total Volume 300 ml | In distribution |
| AF5140MBP-Z | Total Volume 1500 ml | In distribution |
| VN3100MX-F | Total Volume 300 ml | In distribution |
| VN2000MB-D23 | Total Volume 1000 ml | In distribution |
| AF1002MBP | Total Volume 1900 ml | In distribution |
| VN3100MB-K | Total Volume 300 ml | In distribution |
| AF1040MBN-P | Total Volume 1900 ml | In distribution |
| AF5140MB-E | Total Volume 1500 ml | In distribution |
| AF2040MBS | Total Volume 1000 ml | In distribution |
| AF5242MB | Total Volume 1500 ml | In distribution |
| AF1140MB-P | Total Volume 1900 ml | In distribution |
| AF5140MBP | Total Volume 1500 ml | In distribution |
| AF5040MB-E | Total Volume 1500 ml | In distribution |
| AF2140MB-E | Total Volume 1000 ml | In distribution |
| VN2002MB | Total Volume 1000 ml | In distribution |
| AF1140MBP-2 | Total Volume 1900 ml | In distribution |
| AF2142MBP | Total Volume 1000 ml | In distribution |
| VN3100MBP | Total Volume 300 ml | In distribution |
| AF5140MC | Total Volume 1500 ml | In distribution |
| AF2142MB-I | Total Volume 1000 ml | In distribution |
| AF1140MB-N | Total Volume 1900 ml | In distribution |
| VN2000MX-M | Total Volume 1000 ml | In distribution |
| AF3100MC-2 | Total Volume 300 ml | In distribution |
| AF1140MBP-T | Total Volume 1900 ml | In distribution |
| AF1040MCT-I | Total Volume 1900 ml | In distribution |
| AF5000MB | Total Volume 1500 ml | In distribution |
| VN2100MCP | Total Volume 1000 ml | In distribution |
| SS3200MBP | In distribution | |
| VN3100MXK-2 | Total Volume 300 ml | In distribution |
| VN3100MB-B | Total Volume 300 ml | In distribution |
| VN3100MCP-2 | Total Volume 300 ml | In distribution |
| AF5000MBP | Total Volume 1500 ml | In distribution |
| AF5140MBPWTD5 | Total Volume 1500 ml | In distribution |
| AF4040MB | Total Volume 300 ml | In distribution |
| AF1140MBP-M5 | Total Volume 1900 ml | In distribution |
| AF2142MC-3 | Total Volume 1000 ml | In distribution |
| SS3200MB-D1 | Total Volume 250 ml | In distribution |
| VN5000MX | Total Volume 1500 ml | In distribution |
| VN3100MB-I | Total Volume 300 ml | In distribution |
| SC7000B | Total Volume 300 ml | In distribution |
| AF5140MB-PW | Total Volume 1500 ml | In distribution |
| VN2002MCP | Total Volume 1000 ml | In distribution |
| VN2000MX | Total Volume 1000 ml | In distribution |
| AF3140MB-M1 | Total Volume 300 ml | In distribution |
| VN3100OB | Total Volume 300 ml | In distribution |
| SS3200MB-MMC | Total Volume 250 ml | In distribution |
| AF1140MB-9 | Total Volume 1900 ml | In distribution |
| SC7001C | Total Volume 300 ml | In distribution |
| AF2140MBP | Total Volume 1000 ml | In distribution |
| AF2140MC | Total Volume 1000 ml | In distribution |
| VT3000 | In distribution | |
| VN2002MBP | Total Volume 1000 ml | In distribution |
| SC9001C-F | Total Volume 1900 ml | In distribution |
| VN2002MX | Total Volume 1000 ml | In distribution |
| AF2100MB | Total Volume 1000 ml | In distribution |
| VN3104MBP-2B | Total Volume 300 ml | In distribution |
| VN3100MB-2 | Total Volume 300 ml | In distribution |
| VN3000MB | Total Volume 300 ml | In distribution |
| VN2100MB | Total Volume 1000 ml | In distribution |
| AF1100MB | Total Volume 1900 ml | In distribution |
| AF2144MB | Total Volume 1000 ml | In distribution |
| VN2102MX-F | Total Volume 1000 ml | In distribution |
| VN2100MC | Total Volume 1000 ml | In distribution |
| AF2040MB-E | Total Volume 1000 ml | In distribution |
| VN5000MB | Total Volume 1500 ml | In distribution |
| AF3140MB-D1 | Total Volume 300 ml | In distribution |
| AF2140MBP-K | Total Volume 1000 ml | In distribution |
| AF2142MBS-P | Total Volume 1000 ml | In distribution |
| VN4100MCP | Total Volume 550 ml | In distribution |
| BVM800 | Total Volume 1000 ml | In distribution |
| VN3100MB-M1 | Total Volume 300 ml | In distribution |
| AF2242MBP | Total Volume 1000 ml | In distribution |
| AF5140MB-ST | Total Volume 1500 ml | In distribution |
| AF5040MBP | Total Volume 1500 ml | In distribution |
| 10889483103128 | Total Volume 250 ml | In distribution |
| VN2100MCP-2 | Total Volume 1000 ml | In distribution |
| VN5003MX | Total Volume 1500 ml | In distribution |
| VN3100MB-M00-0 | Total Volume 300 ml | In distribution |
| VN3100MBP-000 | Total Volume 300 ml | In distribution |
| AF5100MB-D5 | Total Volume 1500 ml | In distribution |
| AF5100MC | Total Volume 1500 ml | In distribution |
| AF3140MB-D2 | Total Volume 300 ml | In distribution |
| SS3204MC-P2 | In distribution | |
| AF5140MBS-P | Total Volume 1500 ml | In distribution |
| AF2142OB | Total Volume 1000 ml | In distribution |
| SC8000B | Total Volume 1000 ml | In distribution |
| AF2000MB-E | Total Volume 1000 ml | In distribution |
| VN3106MC-V | Total Volume 300 ml | In distribution |
| AF1140MB-PW | Total Volume 1900 ml | In distribution |
| BVM500 | Total Volume 1500 ml | In distribution |
| AF4140MB-Z | Total Volume 550 ml | In distribution |
| AF1143MB | Total Volume 1900 ml | In distribution |
| SC7101B | Total Volume 300 ml | In distribution |
| AF1040MB-S5 | Total Volume 1900 ml | In distribution |
| VN5000MXC | Total Volume 1500 ml | In distribution |
| AF2140MB | Total Volume 1000 ml | In distribution |
| BVM700 | Total Volume 300 ml | In distribution |
| AF2042MB | Total Volume 1000 ml | In distribution |
| VN2102MB | Total Volume 1000 ml | In distribution |
| AF2140OB | Total Volume 1000 ml | In distribution |
| AF2142MB-PW | Total Volume 1000 ml | In distribution |
| VN5000OX | Total Volume 1500 ml | In distribution |
| VN4000MC | Total Volume 550 ml | In distribution |
| VN3100OBP | Total Volume 300 ml | In distribution |
| AF3140MC | Total Volume 300 ml | In distribution |
| AF2102OB | Total Volume 1000 ml | In distribution |
| AF2140MB-3 | Total Volume 1000 ml | In distribution |
| VN2000MXP | Total Volume 1000 ml | In distribution |
| SC9001CF-T | Total Volume 1900 ml | In distribution |
| AF5040MBP-Z | Total Volume 1500 ml | In distribution |
| AF3100MCP | Total Volume 300 ml | In distribution |
| AF1140MB-R | Total Volume 1900 ml | In distribution |
| VN3106MC-M1-2V | Total Volume 300 ml | In distribution |
| VN3100MBP-D1 | Total Volume 300 ml | In distribution |
| VN2100MBP | Total Volume 1000 ml | In distribution |
| VN3106MCPF-M1V | Total Volume 300 ml | In distribution |
| AF2100MCP | Total Volume 1000 ml | In distribution |
| AF2102MCP | Total Volume 1000 ml | In distribution |
| AF5140MB-OT | Total Volume 1500 ml | In distribution |
| AF2140MBS-I | Total Volume 1000 ml | In distribution |
| VN4100MCFB-3 | Total Volume 550 ml | In distribution |
| VN5000MXP | Total Volume 1500 ml | In distribution |
| AF5140MB | Total Volume 1500 ml | In distribution |
| AF2140MBP-E | Total Volume 1000 ml | In distribution |
| VN3100MB-M01 | Total Volume 300 ml | In distribution |
| SS3200MB | Total Volume 250 ml | In distribution |
| VN5000MBPF-I | Total Volume 1500 ml | In distribution |
| AF4100MB-D123 | Total Volume 550 ml | In distribution |
| VN3200MB-D1 | Total Volume 300 ml | In distribution |
| AF1140MB-T | Total Volume 1900 ml | In distribution |
| AF2242MB | Total Volume 1000 ml | In distribution |
| AF1100MX | Total Volume 1900 ml | In distribution |
| AF4100MBP-M2 | Total Volume 550 ml | In distribution |
| VN5000MC-N | Total Volume 1500 ml | In distribution |
| AF3140MCPF | Total Volume 300 ml | In distribution |
| VN5000MX-N | Total Volume 1500 ml | In distribution |
| AF1000MC-N | Total Volume 1900 ml | In distribution |
| AF2140MB-N | In distribution | |
| VN5000MX-R | Total Volume 1500 ml | In distribution |
| AF3100MB | Total Volume 300 ml | In distribution |
| AF5140MBP-D6 | Total Volume 1500 ml | In distribution |
| AF3140OB | Total Volume 300 ml | In distribution |
| VN3100MBP-3M | Total Volume 300 ml | In distribution |
| VN3100MB-PW2 | Total Volume 300 ml | In distribution |
| VN5000MX-F | Total Volume 1500 ml | In distribution |
| SS3200MBF | In distribution | |
| VN2000MBP | Total Volume 1000 ml | In distribution |
| VN3100MB-N | Total Volume 300 ml | In distribution |
| AF5140MBPW-D5 | Total Volume 1500 ml | In distribution |
| AF5040MBP-E | Total Volume 1500 ml | In distribution |
| AF5142OB | Total Volume 1500 ml | In distribution |
| AF1040MBP | Total Volume 1900 ml | In distribution |
| AF2100MB-3 | Total Volume 1000 ml | In distribution |
| AF1140MBS-K | Total Volume 1900 ml | In distribution |
| BVM800-3 | Total Volume 1000 ml | In distribution |
| 10889483100646 | Total Volume 300 ml | In distribution |
| SC9001C | Total Volume 1900 ml | In distribution |
| AF5000MC-I | Total Volume 1500 ml | In distribution |
| AF1040MBS | Total Volume 1900 ml | In distribution |
| AFI2142MB | Total Volume 1000 ml | In distribution |
| AF4100MB | Total Volume 550 ml | In distribution |
| AF5140MB-Z | Total Volume 1500 ml | In distribution |
| VN2000MBP-D13 | Total Volume 1000 ml | In distribution |
| AF5040MB | Total Volume 1500 ml | In distribution |
| AF1100MC | Total Volume 1900 ml | In distribution |
| AF5140MB-F | Total Volume 1500 ml | In distribution |
| AF2140MB-D4 | Total Volume 1000 ml | In distribution |
| AF5142MBP | Total Volume 1500 ml | In distribution |
| VN2100MBF | Total Volume 1000 ml | In distribution |
| VN2000MX-K | Total Volume 1000 ml | In distribution |
| AF1040MB | Total Volume 1900 ml | In distribution |
| SS3200MBP-2I | Total Volume 250 ml | In distribution |
| VN3106MC-D2V | Total Volume 300 ml | In distribution |
| AF3040MBN | Total Volume 300 ml | In distribution |
| AF2040MBP | Total Volume 1000 ml | In distribution |
| AF1040MBC | Total Volume 1900 ml | In distribution |
| AF1142MBP | Total Volume 1900 ml | In distribution |
| AF2002MB | Total Volume 1000 ml | In distribution |
| SC9001C-C | Total Volume 1900 ml | In distribution |
| AF2000MB | Total Volume 1000 ml | In distribution |
| BVM900 | Total Volume 1900 ml | In distribution |
| VS0600-C | In distribution | |
| AF5140MBP-E | Total Volume 1500 ml | In distribution |
| VN5102MC | Total Volume 1500 ml | In distribution |
| AF1000MB | Total Volume 1900 ml | In distribution |
| AF1140MB-E | Total Volume 1900 ml | In distribution |
| AF3100MBP-D12 | Total Volume 300 ml | In distribution |
| AF4140MB-M24 | Total Volume 550 ml | In distribution |
| AF2102MBP-M3 | Total Volume 1000 ml | In distribution |
| AFD5140MB-T | Total Volume 1500 ml | In distribution |
| AF5100OB | Total Volume 1500 ml | In distribution |
| AF3100OB | Total Volume 300 ml | In distribution |
| VN3000MBP | Total Volume 300 ml | In distribution |
| VN2102MBF-I | Total Volume 1000 ml | In distribution |
| AF2140MB-S | Total Volume 1000 ml | In distribution |
| AF3100MC | Total Volume 300 ml | In distribution |
| AF3140MB-M0 | Total Volume 300 ml | In distribution |
| AF5140MB-2 | Total Volume 1500 ml | In distribution |
| AF2100MC | Total Volume 1000 ml | In distribution |
| AF1140MBP-K | Total Volume 1900 ml | In distribution |
| VN3100MBF | Total Volume 300 ml | In distribution |
| AF2142MCP-D4 | Total Volume 1000 ml | In distribution |
| AF2142MBP-E | Total Volume 1000 ml | In distribution |
| AF2142MB-3 | Total Volume 1000 ml | In distribution |
| AF5000MB-E | Total Volume 1500 ml | In distribution |
| VN3000MC-N | Total Volume 300 ml | In distribution |
| AF5140MB-IT | Total Volume 1500 ml | In distribution |
| VN2200MBP | Total Volume 1000 ml | In distribution |
| AF3140MCP | Total Volume 300 ml | In distribution |
| VN5100MB-F | Total Volume 1500 ml | In distribution |
| VN5003MX-R | Total Volume 1500 ml | In distribution |
| AF5140MBP-I | Total Volume 1500 ml | In distribution |
| AF5140MC-D5G8 | Total Volume 1500 ml | In distribution |
| AF3000MB | Total Volume 300 ml | In distribution |
| SC9001B | Total Volume 1900 ml | In distribution |
| AF3144MCP-M1M00 | Total Volume 300 ml | In distribution |
| SC8001BP | Total Volume 1000 ml | In distribution |
| AF3100MB-M01 | Total Volume 300 ml | In distribution |
| AF3140MB | Total Volume 300 ml | In distribution |
| VN3100MBP-2B | Total Volume 300 ml | In distribution |
| VN3100MC-2 | Total Volume 300 ml | In distribution |
| VN3100MBP-2 | Total Volume 300 ml | In distribution |
| AF3100MBP-M01 | Total Volume 300 ml | In distribution |
| VN2102MC-B | Total Volume 1000 ml | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K012842 | 2001-09-18 |
| K913900 | 1992-01-07 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
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.