Ventlab
Ventlab’s hyperinflation system is a manual breathing-bag assembly used to deliver controlled positive-pressure breaths through a face mask. The listed set specifies a half-liter bag,…
Ventlab’s hyperinflation system is a manual breathing-bag assembly used to deliver controlled positive-pressure breaths through a face mask. The listed set specifies a half-liter bag, pressure manometer, pop-off valve, pressure tubing and a size 2 mask.
The breathing bag provides the inflation volume; the manometer displays pressure and the pop-off valve limits pressure according to the selected component. AirLife lists mask, bag and pressure-control options across the Ventlab family.
Listed Item
1/2 Liter Hyperinflation System w/ manometer, pop-off, Pressure Tubing & Size 2 blow mold mask
Pressure Components
AirLife offers manometer and pop-off valve options, including color-coded pressure displays and different valve settings. These options distinguish pressure-control configurations within the family.
2manufacturers in China registered for this device type
129catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
Record
| Listed by | Ventlab, LLC, United States |
|---|---|
| FDA product code | NHK |
| Device type | Resuscitator, Manual, Non Self-Inflating |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Record published | 2016-12-20 |
| Record revised | 2024-12-31 (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 |
| Storage | Special storage condition: Store at room temperature. Do not get wet. |
| Packaging | Box of 10 |
| Sizes | Total volume 0.25 to 3 l; total volume 0.5 ml |
| Distribution end date | 2026-05-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HS1250-M | Total Volume 0.5 l | In distribution |
| HS1150-HM | Total Volume.5 l | In distribution |
| HS4421 | Total Volume 2 l | In distribution |
| HS4531 | Total Volume 3 l | In distribution |
| HS4011-B | Total Volume 1 l | In distribution |
| HS4021-O | Total Volume 2 l | In distribution |
| 3002HZ | Total Volume 1 l | In distribution |
| HS1050-H | Total Volume.5 l | In distribution |
| 1000HZ | Total Volume 0.5 l | In distribution |
| HS4154 | Total Volume 0.5 l | In distribution |
| HS1050-M100 | Total Volume.5 ml | In distribution |
| HS4254 | Total Volume 0.5 l | In distribution |
| HS31150 | Total Volume 0.5 l | In distribution |
| HS4411 | Total Volume 1 l | In distribution |
| 3006HZ | Total Volume 0.5 l | In distribution |
| HS34031 | Total Volume 3 l | In distribution |
| HM05 | Total Volume 0.5 l | In distribution |
| HM20 | Total Volume 2 l | In distribution |
| HS4251 | Total Volume.5 l | In distribution |
| HS4041-M00 | Total Volume.25 l | In distribution |
| HM025 | Total Volume 0.25 l | In distribution |
| HS4031 | Total Volume 3 l | In distribution |
| HS4011 | In distribution | |
| HS4311 | Total Volume 1 l | In distribution |
| HS1050-1 | Total Volume 0.5 l | In distribution |
| HS1250 | Total Volume 0.5 l | In distribution |
| HS4250 | Total Volume.5 l | In distribution |
| HS4041 | Total Volume.25 l | In distribution |
| 2010HZ | Total Volume 0.5 l | In distribution |
| HS4041-B | Total Volume.25 l | In distribution |
| HS34141 | Total Volume.25 l | In distribution |
| HS1050-E | Total Volume.5 ml | In distribution |
| HS1040 | Total Volume 0.25 l | In distribution |
| 1001HZ | Total Volume 2 l | In distribution |
| HS34421 | Total Volume 2 l | In distribution |
| HS1150-1CM | Total Volume.5 l | In distribution |
| 2009HZ | Total Volume 0.5 l | In distribution |
| HS4321 | Total Volume 2 l | In distribution |
| 2014HZ | Total Volume 0.5 l | In distribution |
| HS4151-D2 | Total Volume.5 l | In distribution |
| HS4001 | In distribution | |
| 3003HZ | Total Volume 2 l | In distribution |
| HS34041 | Total Volume 0.25 l | In distribution |
| HS4051-M012 | Total Volume.5 l | In distribution |
| HS4020 | Total Volume 2 l | In distribution |
| HS1150 | Total Volume.5 l | In distribution |
| HS1050-A | Total Volume.5 l | In distribution |
| HS4051 | Total Volume.5 l | In distribution |
| HS1030 | Total Volume 3 l | In distribution |
| HS1020 | Total Volume 2 l | In distribution |
| 2007HZ | Total Volume 0.5 l | In distribution |
| 3001HZ | Total Volume 0.5 l | In distribution |
| HS4011-K | Total Volume 1 l | In distribution |
| HS31050 | Total Volume 0.5 l | In distribution |
| 1100HZ | Total Volume 1 l | In distribution |
| HM10 | Total Volume 1 l | In distribution |
| HS4351-M | Total Volume.5 l | In distribution |
| HS1000 | In distribution | |
| HS4251X | Total Volume.5 l | In distribution |
| HS4521 | Total Volume 2 l | In distribution |
| HS4111 | Total Volume 1 l | In distribution |
| HS1310 | Total Volume 1 l | In distribution |
| 2002HZ | Total Volume 0.5 l | In distribution |
| 2006HZ | Total Volume 0.5 l | In distribution |
| HS1010 | Total Volume 1 l | In distribution |
| HS34311 | Total Volume 1 l | In distribution |
| HM30 | Total Volume 3 l | In distribution |
| 2003HZ | Total Volume 2 l | In distribution |
| HS1050-G | Total Volume.5 l | In distribution |
| HS4151-M0 | Total Volume.5 l | In distribution |
| 1003HZ | Total Volume 0.5 l | In distribution |
| HS4011-T | Total Volume 2 l | In distribution |
| 2005HZ | Total Volume 0.5 l | In distribution |
| 2001HZ | Total Volume 1 l | In distribution |
| 2008HZ | Total Volume 0.5 l | In distribution |
| 2012HZ | Total Volume 1 l | In distribution |
| 95788 | In distribution | |
| HS1530 | Total Volume 3 l | In distribution |
| HS4251-D2X | Total Volume.5 l | In distribution |
| 3005HZ | Total Volume 0.5 l | In distribution |
| HS1150M | Total Volume 0.5 l | In distribution |
| 2011HZ | Total Volume 0.5 l | In distribution |
| HS4251-X | Total Volume.5 l | In distribution |
| HS31030 | Total Volume 3 l | In distribution |
| 3000HZ | Total Volume 0.5 l | In distribution |
| HS4151 | Total Volume.5 l | In distribution |
| HS31250 | Total Volume 0.5 l | In distribution |
| HS34021 | Total Volume 2 l | In distribution |
| HS4000 | In distribution | |
| HS4251-M | Total Volume.5 l | In distribution |
| HS1050 | Total Volume 0.5 l | In distribution |
| HS4151-M | Total Volume.5 l | In distribution |
| HS4050 | Total Volume.5 l | In distribution |
| HS1420 | Total Volume 2 l | In distribution |
| HS4151-D2Z | Total Volume.5 l | In distribution |
| HS4011-O | Total Volume 1 l | In distribution |
| HS4021 | Total Volume 2 l | In distribution |
| HS4241 | Total Volume.25 l | In distribution |
| HS1001 | In distribution | |
| 2000HZ | Total Volume 0.5 l | In distribution |
| 3004HZ | Total Volume 0.5 l | In distribution |
| HS4054 | Total Volume 0.5 l | In distribution |
| HS4051-M0-00T | Total Volume.5 l | In distribution |
| 2004HZ | Total Volume 1 l | In distribution |
| HS31040 | Total Volume 0.25 l | In distribution |
| HS31020 | Total Volume 2 l | In distribution |
| HS31530 | Total Volume 3 l | In distribution |
| HS34151 | Total Volume.5 l | Withdrawn |
| HS34011 | Total Volume 1 l | Withdrawn |
| HS4251-D2 | Total Volume.5 l | Withdrawn |
| HS4051-R2 | Total Volume.5 l | Withdrawn |
| HS34050-MMC | Total Volume 0.5 l | Withdrawn |
| HS4051-M0-00 | Total Volume.5 l | Withdrawn |
| HS4211 | Total Volume 1 l | Withdrawn |
| HS4051-O | Total Volume.5 l | Withdrawn |
| HS34051 | Total Volume.5 l | Withdrawn |
| HS34251 | Total Volume 1 l | Withdrawn |
| HS4051-M00-1-2Z | Total Volume.5 l | Withdrawn |
| HS4051-P | Total Volume.5 l | Withdrawn |
| HS4151-S | Total Volume.5 l | Withdrawn |
| HS4051-K | Total Volume.5 l | Withdrawn |
| HS34251 | Total Volume.5 l | Withdrawn |
| HS4151-MZ | Total Volume.5 l | Withdrawn |
| HS4150 | Total Volume.5 l | Withdrawn |
| HS4051-B | Total Volume.5 l | Withdrawn |
| HS4051-T | Total Volume.5 l | Withdrawn |
| HS4051-M0 | Total Volume.5 l | Withdrawn |
| HS4051-C | Total Volume.5 l | Withdrawn |
| HS4141 | Total Volume.25 l | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hyperinflation System | Mercury Medical Enterprises, LLC | 64 |
| Portex | ICU Medical, Inc | 45 |
| NuFLO2 Hyperinflation System | Mercury Medical Enterprises, LLC | 44 |
| Venti.Plus | Galemed Corp. | 6 |
| Venti.Plus | GaleMed (Xiamen) Co., Ltd. | 4 |
| Breathing Bag | Mercury Medical Enterprises, LLC | 4 |
| Endure Industries | Endure Industries, Inc. | 2 |
| Disposable Medical Hyperinflation System | SunMed Group Holdings, LLC | 2 |
| Curaplex | Bound Tree Medical, LLC | 1 |
| Ventlab Hyperinflation System | Ventlab, LLC | 1 |
| Hyperinflation | Mercury Medical Enterprises, LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020281 | 2002-02-11 |
| K013308 | 2001-12-20 |
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.