Ventlab
Infant BAG, Mask W/ Corrug Tube Reservoir, POP-OFF, Manometer & Peep Attached
71manufacturers in China registered for this device type
205catalogue numbers in this listing
1510(k) clearance
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 | Ventlab, LLC, United States |
|---|---|
| FDA product code | BSJ |
| Device type | Mask, Gas, Anesthetic |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5550 |
| Premarket notification | Exempt |
| Record published | 2016-11-23 |
| Record revised | 2025-11-24 (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 4 to 1900 ml |
| Distribution end date | 2026-04-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT3025 | Total Volume 550 ml | In distribution |
| BT2234 | Total Volume 300 ml | In distribution |
| BT2416 | Total Volume 300 ml | In distribution |
| VR5100-70 | In distribution | |
| BT2035 | Total Volume 300 ml | In distribution |
| BT4024 | Total Volume 1000 ml | In distribution |
| BT4030 | Total Volume 1000 ml | In distribution |
| VR6100-20 | In distribution | |
| BT2434FK | Total Volume 300 ml | In distribution |
| BT5007N | Total Volume 1900 ml | In distribution |
| VR5000 | In distribution | |
| BT4022 | Total Volume 1000 ml | In distribution |
| VR4700-40 | In distribution | |
| BT5012 | Total Volume 1900 ml | In distribution |
| VR1400-100 | In distribution | |
| BT2415 | Total Volume 300 ml | In distribution |
| BT2220F | Total Volume 300 ml | In distribution |
| VR1600-20 | In distribution | |
| BT4033 | Total Volume 1000 ml | In distribution |
| VR1400-20 | In distribution | |
| VR4700-100 | In distribution | |
| VR5000-50-C | In distribution | |
| VR3400-20 | In distribution | |
| BT5004K | Total Volume 1900 ml | In distribution |
| BT4006 | Total Volume 1000 ml | In distribution |
| VR5100-100 | In distribution | |
| VR4500-40 | In distribution | |
| BT2416F | Total Volume 300 ml | In distribution |
| VR2100-20 | In distribution | |
| BT2048 | Total Volume 300 ml | In distribution |
| VR4900-20 | In distribution | |
| VR4100-20 | In distribution | |
| BT3034 | Total Volume 550 ml | In distribution |
| BT2034W | Total Volume 300 ml | In distribution |
| VR5100-50-C | In distribution | |
| BT3019 | Total Volume 550 ml | In distribution |
| VR6100 | In distribution | |
| VR0040-20 | In distribution | |
| VR6400-20 | In distribution | |
| BT4001 | Total Volume 1000 ml | In distribution |
| VR4400-20 | In distribution | |
| BT2215 | Total Volume 300 ml | In distribution |
| BT5004FK | Total Volume 1900 ml | In distribution |
| VR1100-40-C | In distribution | |
| BT2027 | Total Volume 300 ml | In distribution |
| BT2016 | Total Volume 300 ml | In distribution |
| BT2416K | Total Volume 300 ml | In distribution |
| VR5100-20 | In distribution | |
| VR5700-68 | In distribution | |
| BT4040 | Total Volume 1000 ml | In distribution |
| VR6400-50 | In distribution | |
| VR5400-20 | In distribution | |
| BT2025 | Total Volume 300 ml | In distribution |
| BT2004 | Total Volume 300 ml | In distribution |
| BT2234FK | Total Volume 300 ml | In distribution |
| BT5003K | Total Volume 1900 ml | In distribution |
| VR5400-68 | In distribution | |
| BT2216 | Total Volume 300 ml | In distribution |
| BT3030 | Total Volume 550 ml | In distribution |
| BT2029 | Total Volume 300 ml | In distribution |
| VR6700-100 | In distribution | |
| BT2023 | Total Volume 300 ml | In distribution |
| VR4400-40 | In distribution | |
| VR5100 | In distribution | |
| VR7500-50 | In distribution | |
| VR1100-20 | In distribution | |
| BT2011 | Total Volume 300 ml | In distribution |
| VR1400-40 | In distribution | |
| BT2040 | Total Volume 300 ml | In distribution |
| BT2420F | Total Volume 300 ml | In distribution |
| VR1100-100 | In distribution | |
| VR2100 | In distribution | |
| VR2900-40 | In distribution | |
| BT5007FK | Total Volume 1900 ml | In distribution |
| BT2434 | Total Volume 300 ml | In distribution |
| VR5400-50 | In distribution | |
| VR5700-50 | In distribution | |
| BT2415F | Total Volume 300 ml | In distribution |
| VR6500-50 | In distribution | |
| BT2014 | Total Volume 300 ml | In distribution |
| VR7700-50 | In distribution | |
| VR6700-20 | In distribution | |
| VR5500-50 | In distribution | |
| BT2032 | Total Volume 300 ml | In distribution |
| BT2434F | Total Volume 300 ml | In distribution |
| VR0900-20 | In distribution | |
| BT5023F | Total Volume 1900 ml | In distribution |
| BT2215K | Total Volume 300 ml | In distribution |
| VR5100-50 | In distribution | |
| BT2007 | Total Volume 300 ml | In distribution |
| BT5007 | Total Volume 1900 ml | In distribution |
| VR5000-100 | In distribution | |
| BT5026 | Total Volume 1900 ml | In distribution |
| VR5000-50 | In distribution | |
| VR0400-20 | In distribution | |
| BT3018 | Total Volume 550 ml | In distribution |
| VR5000-80 | In distribution | |
| BT2026 | Total Volume 300 ml | In distribution |
| BT2420 | Total Volume 300 ml | In distribution |
| BT2037 | Total Volume 300 ml | In distribution |
| BT2200FK | Total Volume 300 ml | In distribution |
| VR3600-20 | In distribution | |
| BT5006 | Total Volume 1900 ml | In distribution |
| 812-0006-01 | In distribution | |
| BT4006-N | Total Volume 1000 ml | In distribution |
| BT4019 | Total Volume 1000 ml | In distribution |
| VR2600-20 | In distribution | |
| BT5007K | Total Volume 1900 ml | In distribution |
| VR5700-100 | In distribution | |
| BT2234F | Total Volume 300 ml | In distribution |
| BT2215F | Total Volume 300 ml | In distribution |
| BT2420FK | Total Volume 300 ml | In distribution |
| BT2008 | Total Volume 300 ml | In distribution |
| BT4016 | Total Volume 1000 ml | In distribution |
| BT3027 | Total Volume 550 ml | In distribution |
| BT4045 | Total Volume 1000 ml | In distribution |
| VR6700-50 | In distribution | |
| VR7700-20 | In distribution | |
| BT3031 | Total Volume 550 ml | In distribution |
| BT5003 | Total Volume 1900 ml | In distribution |
| BT4018 | Total Volume 1000 ml | In distribution |
| BT2034 | Total Volume 300 ml | In distribution |
| VR3100-20 | In distribution | |
| VR6400-68 | In distribution | |
| VR6500-20 | In distribution | |
| VR7700-100 | In distribution | |
| BT4013 | Total Volume 1000 ml | In distribution |
| VR2100-40-C | In distribution | |
| BT5007F | Total Volume 1900 ml | In distribution |
| BT2415K | Total Volume 300 ml | In distribution |
| BT3012 | Total Volume 300 ml | In distribution |
| BT4015 | Total Volume 1000 ml | In distribution |
| VR4400-100 | In distribution | |
| VR2100-100 | In distribution | |
| VR5900-50 | In distribution | |
| BT2015 | Total Volume 300 ml | In distribution |
| VR4900-40 | In distribution | |
| BT2216K | Total Volume 300 ml | In distribution |
| VR6100-100 | In distribution | |
| BT5003FK | Total Volume 1900 ml | In distribution |
| VR2700-40 | In distribution | |
| BT2020 | Total Volume 300 ml | In distribution |
| BT5004 | Total Volume 1900 ml | In distribution |
| VR2700-100 | In distribution | |
| VR6100-50 | In distribution | |
| VR6100-68 | In distribution | |
| VR2400-20 | In distribution | |
| VR6700-68 | In distribution | |
| BT2220 | Total Volume 300 ml | In distribution |
| BT2024 | Total Volume 300 ml | In distribution |
| BT2216F | Total Volume 300 ml | In distribution |
| VR5000-20 | In distribution | |
| VR3100-40-C | Withdrawn | |
| VR1400-180 | Withdrawn | |
| 812-0011-01 | Withdrawn | |
| VR1100-200 | Withdrawn | |
| VR2400-160 | Withdrawn | |
| VR2700-20 | Withdrawn | |
| VR3900-40 | Withdrawn | |
| VR4100-100 | Withdrawn | |
| VR7500-20 | Withdrawn | |
| VR4100-40-C | Withdrawn | |
| 812-0009-01 | Withdrawn | |
| VR3700-20 | Withdrawn | |
| VR4700-20 | Withdrawn | |
| VR2100-40 | Withdrawn | |
| VR3400-40 | Withdrawn | |
| VR3100-100 | Withdrawn | |
| VR2100-160 | Withdrawn | |
| VR0040-300 | Withdrawn | |
| VR2900-20 | Withdrawn | |
| VR5700-20 | Withdrawn | |
| VR4100-40 | Withdrawn | |
| 812-0010-01 | Withdrawn | |
| VR1100-40 | Withdrawn | |
| VR2400-100 | Withdrawn | |
| VR0040-100 | Withdrawn | |
| BT9003 | Total Volume 550 ml | Withdrawn |
| VR1700-40 | Withdrawn | |
| 4-0110-00 | Total Volume 4 ml | Withdrawn |
| 812-0007-01 | Withdrawn | |
| VR0400-40 | Withdrawn | |
| VR4500-20 | Withdrawn | |
| 4-0110-05 | Total Volume 50 ml | Withdrawn |
| VR2700-160 | Withdrawn | |
| VR3100-40 | Withdrawn | |
| VR0040-40 | Withdrawn | |
| VR5500-20 | Withdrawn | |
| 4-0110-01 | Total Volume 10 ml | Withdrawn |
| VR2400-40 | Withdrawn | |
| VR0400-100 | Withdrawn | |
| VR3900-20 | Withdrawn | |
| VR3700-120 | Withdrawn | |
| VR1700-180 | Withdrawn | |
| VR3700-40 | Withdrawn | |
| VR0400-250 | Withdrawn | |
| 4-0110-03 | Total Volume 30 ml | Withdrawn |
| VR3100-120 | Withdrawn | |
| VR3400-120 | Withdrawn | |
| 812-0008-01 | Withdrawn | |
| VR0900-40 | Withdrawn | |
| VR1900-20 | Withdrawn | |
| 4-0110-02 | Total Volume 20 ml | Withdrawn |
| VR5900-20 | Withdrawn | |
| 4-0110-04 | Total Volume 40 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 49 |
| Rusch | Teleflex Medical LLC | 45 |
| Portex | ICU Medical, Inc | 33 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K903881 | 1990-09-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, 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. |
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.