Medline Industries, Inc.
RESUSCITATOR,MAN.INF,BAG,FILTER,PEEP,CO2
8manufacturers in China registered for this device type
53catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Record published | 2015-10-15 |
| Record revised | 2019-10-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Packaging | Pack of 6, pack of 12, case of 8, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPRM1126K | In distribution | |
| CPRM1126FP | In distribution | |
| CPRM2226F | In distribution | |
| CPRM3312FPC | In distribution | |
| CPRM3412P | In distribution | |
| CPRM3312FP | In distribution | |
| CPRM1116PC | In distribution | |
| CPRM2226FC | In distribution | |
| CPRM3322FC | In distribution | |
| CPRM2216C | In distribution | |
| CPRM1116P | In distribution | |
| CPRM2226 | In distribution | |
| CPRM1116FC | In distribution | |
| CPRM1126FPC | In distribution | |
| CPRM2226C | In distribution | |
| DYNJA128808A | In distribution | |
| CPRM1126C | In distribution | |
| CPRM1126FC | In distribution | |
| CPRM1126PC | In distribution | |
| CPRM1116WM | In distribution | |
| CPRM3322P | In distribution | |
| CPRM2216PC | In distribution | |
| CPRM1116FP | In distribution | |
| CPRM2216FC | In distribution | |
| CPRM3322C | In distribution | |
| CPRM3312P | In distribution | |
| CPRM3312FC | In distribution | |
| CPRM1126 | In distribution | |
| CPRM1116C | In distribution | |
| CPRM1126P | In distribution | |
| CPRM1116 | In distribution | |
| CPRM3322F | In distribution | |
| CPRM2226FPC | In distribution | |
| CPRM3312C | In distribution | |
| CPRM1116F | In distribution | |
| CPRM2226FP | In distribution | |
| CPRM3312F | In distribution | |
| CPRM3312 | In distribution | |
| CPRM1116FPC | In distribution | |
| CPRM2216FPC | In distribution | |
| CPRM3322 | In distribution | |
| CPRM1116CF | In distribution | |
| CPRM2216 | In distribution | |
| CPRM2216FP | In distribution | |
| CPRM3322PC | In distribution | |
| CPRM3322FPC | In distribution | |
| CPRM2226PC | In distribution | |
| CPRM2226P | In distribution | |
| CPRM1116K | In distribution | |
| CPRM3312PC | In distribution | |
| CPRM3322FP | In distribution | |
| CPRM1126F | In distribution | |
| CPRM2216P | 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 |
| 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 |
| 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)
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 | Quantity |
|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2025-05-01 | Class I | Process control | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which | 11,358 |
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.