Rusch
Berman Airway EMERGENCY PACK - Includes 1 each size of 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm and 110mm
84manufacturers in China registered for this device type
129catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (30), Guangdong (18), Jiangsu (12). 20 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 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 84. All 84 manufacturers in China registered for Airway, Oropharyngeal, Anesthesiology
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-14 |
| Record revised | 2025-09-08 (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 |
| Packaging | Box of 10, box of 50, case of 48, box of 12, box of 20, box of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN049460 | 10 | In distribution | |
| IPN049399 | In distribution | ||
| IPN049384 | In distribution | ||
| IPN049476 | In distribution | ||
| IPN049464 | 50 | In distribution | |
| IPN042282 | 10 | In distribution | |
| IPN049402 | In distribution | ||
| IPN924616 | 10 | In distribution | |
| IPN049422 | 50 | In distribution | |
| IPN049421 | 50 | In distribution | |
| IPN049989 | 10 | In distribution | |
| IPN049474 | 10 | In distribution | |
| IPN049447 | In distribution | ||
| IPN049404 | 10 | In distribution | |
| IPN049401 | In distribution | ||
| IPN049397 | 10 | In distribution | |
| 1168 | In distribution | ||
| IPN042276 | 10 | In distribution | |
| IPN049406 | 10 | In distribution | |
| IPN049409 | 10 | In distribution | |
| IPN049470 | 10 | In distribution | |
| IPN049472 | 10 | In distribution | |
| IPN049429 | In distribution | ||
| IPN049412 | 10 | In distribution | |
| IPN049407 | 10 | In distribution | |
| IPN924570 | In distribution | ||
| IPN049990 | In distribution | ||
| IPN049376 | 50 | In distribution | |
| IPN042303 | 10 | In distribution | |
| IPN049419 | In distribution | ||
| IPN042275 | 10 | In distribution | |
| IPN049410 | 10 | In distribution | |
| IPN049393 | 10 | In distribution | |
| IPN049479 | In distribution | ||
| IPN049380 | 50 | In distribution | |
| IPN049465 | In distribution | ||
| IPN924569 | In distribution | ||
| IPN049378 | 50 | In distribution | |
| IPN049436 | 50 | In distribution | |
| IPN049432 | 50 | In distribution | |
| IPN049415 | In distribution | ||
| IPN042280 | 10 | In distribution | |
| IPN049462 | In distribution | ||
| IPN049390 | 10 | In distribution | |
| IPN049481 | In distribution | ||
| IPN049392 | 10 | In distribution | |
| IPN049411 | 10 | In distribution | |
| IPN049428 | In distribution | ||
| IPN924565 | In distribution | ||
| IPN049414 | In distribution | ||
| IPN049396 | 10 | In distribution | |
| IPN044326 | In distribution | ||
| IPN049473 | 10 | In distribution | |
| IPN042279 | 10 | In distribution | |
| IPN049438 | In distribution | ||
| IPN049435 | 50 | In distribution | |
| IPN049466 | In distribution | ||
| IPN049440 | In distribution | ||
| IPN049418 | In distribution | ||
| IPN042302 | 10 | In distribution | |
| IPN049478 | In distribution | ||
| IPN049427 | In distribution | ||
| IPN049413 | In distribution | ||
| IPN924566 | In distribution | ||
| IPN049426 | In distribution | ||
| IPN049468 | In distribution | ||
| IPN049461 | 10 | In distribution | |
| IPN049398 | In distribution | ||
| 1166 | In distribution | ||
| IPN049391 | 10 | In distribution | |
| IPN924699 | In distribution | ||
| IPN049374 | 50 | In distribution | |
| IPN042278 | 10 | In distribution | |
| 1165 | In distribution | ||
| IPN049475 | 10 | In distribution | |
| IPN042274 | 10 | In distribution | |
| IPN049423 | 50 | In distribution | |
| IPN042313 | In distribution | ||
| IPN924568 | In distribution | ||
| IPN924572 | In distribution | ||
| IPN049442 | In distribution | ||
| IPN049417 | In distribution | ||
| IPN049433 | 50 | In distribution | |
| IPN049480 | In distribution | ||
| IPN049441 | In distribution | ||
| IPN924571 | In distribution | ||
| IPN049385 | In distribution | ||
| 1164 | In distribution | ||
| IPN049471 | 10 | In distribution | |
| IPN049467 | 50 | In distribution | |
| IPN042281 | In distribution | ||
| IPN049459 | In distribution | ||
| IPN924615 | 10 | In distribution | |
| IPN049400 | In distribution | ||
| IPN924567 | In distribution | ||
| IPN049405 | 10 | In distribution | |
| IPN049388 | In distribution | ||
| IPN049386 | In distribution | ||
| IPN049477 | In distribution | ||
| 1169 | In distribution | ||
| IPN049377 | 50 | In distribution | |
| IPN049430 | In distribution | ||
| IPN049439 | In distribution | ||
| IPN049431 | In distribution | ||
| 1170 | In distribution | ||
| IPN049988 | 10 | In distribution | |
| IPN049929 | In distribution | ||
| 1167 | In distribution | ||
| 1171 | In distribution | ||
| IPN924617 | In distribution | ||
| IPN049395 | 10 | In distribution | |
| IPN049394 | 10 | In distribution | |
| IPN049424 | 50 | In distribution | |
| IPN049375 | 50 | In distribution | |
| IPN049425 | In distribution | ||
| IPN049482 | In distribution | ||
| IPN042277 | In distribution | ||
| IPN049383 | In distribution | ||
| IPN049387 | In distribution | ||
| IPN049416 | In distribution | ||
| IPN049382 | In distribution | ||
| IPN044325 | In distribution | ||
| IPN049437 | In distribution | ||
| IPN049463 | In distribution | ||
| IPN049379 | 50 | In distribution | |
| IPN049403 | 10 | In distribution | |
| IPN049434 | 50 | In distribution | |
| IPN049420 | 50 | In distribution | |
| IPN049408 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMA Airway Management | Teleflex Medical LLC | 444 |
| SourceMark | Sourcemark, LLC. | 94 |
| Curaplex | Bound Tree Medical, LLC | 86 |
| Hudson RCI | Teleflex Medical LLC | 83 |
| SunMed | SunMed Group Holdings, LLC | 66 |
| Medline | Medline Industries, Inc. | 59 |
| LMA | Teleflex Medical LLC | 50 |
| MediChoice | Owens & Minor Distribution, Inc. | 33 |
| ADC® | American Diagnostic Corp. | 32 |
| Air-Q3® | Airlife, Inc. | 32 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
| Airway, Oropharyngeal, Anesthesiology | VBM Medizintechnik Gmbh | 26 |
Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-01-13 | Class II | Other | The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff). | 2640 units | 2016-09-27 |
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.