Curaplex
Curaplex Air-Q sp3G BLS Kit Size 3 with Suction Cath, Connector, ET Tube Holder, and Lube Jelly
84manufacturers in China registered for this device type
86catalogue 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 | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-30 |
| Record revised | 2023-12-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
| Packaging | Case of 10, box of 5, inner bag of 50, case of 30, case of 50, case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 670232-KIT | In distribution | ||
| 670177-KIT | In distribution | ||
| 2010-35050 | In distribution | ||
| 670281-KIT | In distribution | ||
| 2010-35090 | In distribution | ||
| 2010-35060 | In distribution | ||
| 2114-163025 | In distribution | ||
| 020008 | In distribution | ||
| KLTSD404K-DOD | In distribution | ||
| 2114-16305 | Adult 70 to 100kg | In distribution | |
| 2010-34110 | In distribution | ||
| 2114-193025 | In distribution | ||
| 2114-16301 | In distribution | ||
| 670276-KIT | In distribution | ||
| 2010-37110 | 50 | In distribution | |
| 670274-KIT | In distribution | ||
| 2114-16304 | Adult 50 to 70kg | In distribution | |
| SEEGAK | In distribution | ||
| 670275-KIT | In distribution | ||
| 301-0207 | In distribution | ||
| 2114-16302 | In distribution | ||
| KLTSD405K | In distribution | ||
| 2114-163015 | In distribution | ||
| 2114-19304 | In distribution | ||
| 2114-16301 | Neonate up to 5kg | In distribution | |
| 2114-16303 | Adult 30 to 50kg | In distribution | |
| 670234-KIT | In distribution | ||
| 477-KLTSD410 | In distribution | ||
| 670233-KIT | In distribution | ||
| 2114-19301 | Neonate up to 5kg | In distribution | |
| 2114-19305 | In distribution | ||
| 2114-193015 | In distribution | ||
| 670282-KIT | In distribution | ||
| 2010-34100 | In distribution | ||
| 670279-KIT | In distribution | ||
| 2010-35100 | In distribution | ||
| 2114-19302 | In distribution | ||
| KLTSD403K-NG | In distribution | ||
| 021008 | In distribution | ||
| 477-KLTSD411 | In distribution | ||
| 670259-KIT | In distribution | ||
| 2010-35040 | In distribution | ||
| 2114-163025 | Child 20 to 30kg | In distribution | |
| SEEBAK-BX | In distribution | ||
| 2114-193025 | Child 20 to 30kg | In distribution | |
| 2114-163015 | Infant 5 to10kg | In distribution | |
| TC3B-B-HL-ST | In distribution | ||
| 2114-19301 | In distribution | ||
| KLTSD403K | In distribution | ||
| KLTSD405K-NG | In distribution | ||
| 2114-19303 | Adult 30 to 50kg | In distribution | |
| 670277-KIT | In distribution | ||
| 2114-193015 | Infant 5 to 10kg | In distribution | |
| 2010-35110 | In distribution | ||
| 2010-34050 | In distribution | ||
| 2010-34080 | In distribution | ||
| 670280-KIT | In distribution | ||
| 2114-19303 | In distribution | ||
| 670278-KIT | In distribution | ||
| 2010-34040 | In distribution | ||
| 2010-35080 | In distribution | ||
| 2114-19302 | Infant 10 to 20kg | In distribution | |
| 2010-36110 | 50 | In distribution | |
| 2114-16302 | Infant 10 to 20kg | In distribution | |
| 8600-01396 | In distribution | ||
| 2114-16303 | In distribution | ||
| 2114-16304 | In distribution | ||
| KLTSD404K-NG | In distribution | ||
| KLTSD404K | In distribution | ||
| 8600-01228 | In distribution | ||
| 8600-01395 | In distribution | ||
| 477-KLTSD4125 | In distribution | ||
| 477-KLTSD412 | In distribution | ||
| 2010-35070 | In distribution | ||
| 2114-16305 | In distribution | ||
| 8600-01237 | In distribution | ||
| 8600-01397 | In distribution | ||
| 2114-19304 | Adult 50 to 70kg | In distribution | |
| 2010-34070 | In distribution | ||
| 2010-34060 | In distribution | ||
| 020008C | In distribution | ||
| 13027 | In distribution | ||
| 2114-19305 | Adult 70 to 100kg | In distribution | |
| 021007 | In distribution | ||
| 670176-KIT | In distribution | ||
| 2010-34090 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMA Airway Management | Teleflex Medical LLC | 444 |
| Rusch | Teleflex Medical LLC | 129 |
| SourceMark | Sourcemark, LLC. | 94 |
| 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 |
|---|---|---|---|---|---|
| 2020-05-14 | Class II | Process control | Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s air | 167 kits | 2023-12-07 |
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.