Shiley
Cuff Resting,10.1,mm;Inner Diameter,3.5,mm;Distal Length (A),22,mm;Proximal Length 1 (B),34,mm;Proximal Length 2 (C),44,mm
9manufacturers in China registered for this device type
295catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| 510(k) | K151381 |
| Record published | 2017-05-25 |
| Record revised | 2026-06-17 (version 24) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 10, pack_or_inner_pack of 10, case of 5, pack_or_inner_pack of 5, case of 100 |
| Sizes | Outer diameter 2.5 to 13.5 mm; depth 9 mm |
| Distribution end date | 2026-01-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 86236 | End of first ring, 29, MM; End of second ring, 41, MM; End of third ring, 53, MM; | In distribution |
| 86267 | Outer Diameter 5.0 mm | In distribution |
| 86449 | Outer Diameter 6.5 mm | In distribution |
| 86547 | Outer Diameter 5.5 mm | In distribution |
| 76260 | Outer Diameter 6.0 mm | In distribution |
| 86445 | Outer Diameter 4.5 mm | In distribution |
| 18780S | Outer Diameter 10.8 mm | In distribution |
| 18710 | Cuff Resting Diameter,28.6,Millimeter;Inner Diameter,10.0,Millimeter;Size A,107,Millimeter;Size B,127,Millimeter; | In distribution |
| 86055 | Outer Diameter 9.0 mm | In distribution |
| 18865 | Cuff Resting Diameter, 20.6, MM; Inner Diameter, 6.5, MM; Outer Diameter, 9.8, MM; | In distribution |
| 86112 | Outer Diameter 7.5 mm | In distribution |
| 86288 | Outer Diameter 5.5 mm | In distribution |
| 86542 | Outer Diameter 3.0 mm | In distribution |
| 86140 | Cuff Resting,11.5,mm;Inner Diameter,4.0,mm;Distal Length (A),26,mm;Proximal Length 1 (B),39,mm;Proximal Length 2 (C),50,mm | In distribution |
| 86201 | Outer Diameter 5.5 mm | In distribution |
| 86155 | Cuff Resting,15.6,mm;Inner Diameter,5.5,mm;Distal Length (A),30,mm;Proximal Length 1 (B),54,mm;Proximal Length 2 (C),68,mm | In distribution |
| 86013 | Outer Diameter 8.0 mm | In distribution |
| 86053 | Outer Diameter 8.0 mm | In distribution |
| 96360 | Outer Diameter 6.0 mm | In distribution |
| 86400 | Outer Diameter 3.0 mm | In distribution |
| 86235 | Outer Diameter 4.9 mm | In distribution |
| 18890 | Cuff Resting Diameter, 28.6, MM; Inner Diameter, 9.0, MM; Outer Diameter, 13.1, MM; | In distribution |
| 18875S | Outer Diameter 11.2 mm | In distribution |
| 86228 | Inner Diameter, 5.5,Millimeter; Outer Diameter, 7.5, MM; | In distribution |
| 76265 | Outer Diameter 6.5 mm | In distribution |
| 18780 | Cuff Resting Diameter,25.4,Millimeter;Inner Diameter,8.0,Millimeter;Size A,94,Millimeter;Size B,114,Millimeter; | In distribution |
| 18880S | Cuff Resting Diameter, 25.4,Millimeter;Inner Diameter,8.0,Millimeter;Size A,94,Millimeter;Size B,114,Millimeter; | In distribution |
| 86232 | End of First ring, 21, MM; End of Second ring, 33, MM; End of third ring, N/A; | In distribution |
| 76275 | Outer Diameter 7.5 mm | In distribution |
| 86241 | End of first ring, 40, MM; End of second ring, 52, MM; End of third ring, 64, MM; | In distribution |
| 86395 | Outer Diameter 5.5 mm | In distribution |
| 86014 | Outer Diameter 8.5 mm | In distribution |
| 86239 | Inner Diamter,5.5,MM;End of First Ring, 35, MM; End of Second Ring, 47, MM; End of Third Ring, 59, MM | In distribution |
| 86107 | Outer Diameter 5.0 mm | In distribution |
| 86265 | Outer Diameter 4.0 mm | In distribution |
| 86240 | End of first ring, 37, MM; End of second ring, 49, MM; End of third ring, 61, MM; | In distribution |
| 86646 | Outer Diameter 4.5 mm | In distribution |
| 86554 | Cuff Resting Diameter, 31.0, MM; | In distribution |
| 86654 | Outer Diameter 3.5 mm | In distribution |
| 86234 | Outer Diameter 4.2 mm | In distribution |
| 86455 | Outer Diameter 9.5 mm | In distribution |
| 86655 | Outer Diameter 4.0 mm | In distribution |
| 18860 | Cuff Resting Diameter, 20.6, MM; Inner Diameter, 6.0, MM; Outer Diameter, 9.0, MM; | In distribution |
| 109870 | Outer Diameter 7.0 mm | In distribution |
| 86452 | Outer Diameter 8.0 mm | In distribution |
| 86239 | End of first ring, 35, MM; End of second ring, 47, MM; End of third ring, 59, MM; | In distribution |
| 86234 | Outer Diameter 4.2 mm | In distribution |
| 86286 | Outer Diameter 4.5 mm | In distribution |
| 110890 | Cuff Resting Diameter,30.0,Millimeter; | In distribution |
| 86221 | Inner Diameter, 2.0, MM; Outer Diameter, 3.0, MM; | In distribution |
| 109875 | Outer Diameter 7.5 mm | In distribution |
| 76280 | Outer Diameter 8.0 mm | In distribution |
| 18785 | Cuff Resting Diameter,28.6,Millimeter;Inner Diameter,8.5,Millimeter;Size A,97,Millimeter;Size B,117,Millimeter; | In distribution |
| 86235 | End of First ring, 27, MM; End of second ring, 39, MM; end of third ring, 51, MM; | In distribution |
| 86237 | Outer Diameter 6.2 mm | In distribution |
| 86160 | Cuff Resting,17.2,mm;Inner Diameter,6.0,mm;Distal Length (A),34,mm;Proximal Length 1 (B),59,mm;Proximal Length 2 (C),74,mm | In distribution |
| 85590 | Outer Diameter 7.0 mm | In distribution |
| 86544 | Outer Diameter 4.0 mm | In distribution |
| 87455 | Outer Diameter 7.5 mm | In distribution |
| 18880 | Cuff Resting Diameter,25.4,MM;Inner Diameter,8.0,MM;Distal Length (A),94,MM;Proximal Length 1 (B),114,MM | In distribution |
| 18750 | Cuff Resting Diameter,17.4,Millimeter;Inner Diameter,5.0,Millimeter;Size A,78,Millimeter;Size B,98,Millimeter; | In distribution |
| 109880 | Outer Diameter 8.0 mm | In distribution |
| 86553 | Outer Diameter 8.5 mm | In distribution |
| 86240 | Outer Diameter 8.2 mm | In distribution |
| 86047 | Outer Diameter 5.0 mm | In distribution |
| 86288 | End of First Ring, 35, MM; End of Second Ring, 47, MM; End of Third Ring, 59, MM; | In distribution |
| 86145 | Cuff Resting,12.3,mm;Inner Diameter,4.5,mm;Distal Length (A),28,mm;Proximal Length 1 (B),44,mm;Proximal Length 2 (C),56,mm | In distribution |
| 86209 | Outer Diameter 4.0 mm | In distribution |
| 86051 | Outer Diameter 7.0 mm | In distribution |
| 110870 | Outer Diameter 7.0 mm | In distribution |
| 87485 | Outer Diameter 11.4 mm | In distribution |
| 86048 | Outer Diameter 5.5 mm | In distribution |
| 109890 | Cuff Resting Diameter, 31.0,Millimeter; | In distribution |
| 86049 | Outer Diameter 6.0 mm | In distribution |
| 86286 | End of First Ring, 31, MM; End of Second Ring, 43, MM; End of Third Ring, 55, MM; | In distribution |
| 86444 | Outer Diameter 4.0 mm | In distribution |
| 110880 | Cuff Resting Diameter,27.0,Millimeter; | In distribution |
| 18755S | Outer Diameter 7.5 mm | In distribution |
| 86546 | Outer Diameter 5.0 mm | In distribution |
| 86113 | Outer Diameter 8.0 mm | In distribution |
| 18870 | Cuff Resting Diameter,25.4,MM;Inner Diameter,7.0,MM;Distal Length (A),88,MM;Proximal Length 1 (B),108,MM | In distribution |
| 76251 | Outer Diameter 5.0 mm | In distribution |
| 18885 | Cuff Resting Diameter, 28.6, MM; Inner Diameter, 8.5, MM; Outer Diameter, 12.6, MM; | In distribution |
| 110860 | Outer Diameter 6.0 mm | In distribution |
| 86114 | Outer Diameter 8.5 mm | In distribution |
| 86555 | Outer Diameter 9.5 mm | In distribution |
| 87440 | Cuff Resting Diameter,9.6,mm;Inner Diameter,4.0,mm;Distal Length (A),55,mm;Proximal Length (B),67,mm;Proximal Length (C),30,mm | In distribution |
| 87470 | Outer Diameter 9.5 mm | In distribution |
| 86242 | End of first ring, 42, MM; End of second ring, 54, MM; End of third ring, 66, MM; | In distribution |
| 86150 | Cuff Resting,14.2,mm;Inner Diameter,5.0,mm;Distal Length (A),33,mm;Proximal Length (B),49,mm;Proximal Length 2 (C),62,mm | In distribution |
| 86238 | End of first ring, 33, MM; End of second ring, 45, MM; End of third ring, 57, MM; | In distribution |
| 87445 | Cuff Resting Diameter,13.0,mm;Inner Diameter,4.5,mm;Distal Length (A),60,mm;Proximal Length (B),72,mm;Proximal Length (C),38,mm | In distribution |
| 87430 | Outer Diameter 4.4 mm | In distribution |
| 85593 | Outer Diameter 8.5 mm | In distribution |
| 86265 | Outer Diameter 4.0 mm | In distribution |
| 86236 | Outer Diameter 5.5 mm | In distribution |
| 76285 | Cuff Resting Diameter, 28.6, MM; | In distribution |
| 86447 | Outer Diameter 5.5 mm | In distribution |
| 86233 | Outer Diameter 3.6 mm | In distribution |
| 18760S | Outer Diameter 8.2 mm | In distribution |
| 86233 | End of First ring, 23, MM; End of Second ring, 35, MM; End of Third Ring, N/A; | In distribution |
| 86204 | Outer Diameter 7.0 mm | In distribution |
| 18755 | Outer Diameter 7.5 mm | In distribution |
| 109860 | Cuff Resting Diameter, 22.0,Millimeter; | In distribution |
| 18710S | Outer Diameter 13.5 mm | In distribution |
| 85591 | Outer Diameter 7.5 mm | In distribution |
| 86237 | End of first ring, 31, MM; End of second ring, 43, MM; End of third ring, 55, MM; | In distribution |
| 86448 | Outer Diameter 6.0 mm | In distribution |
| 18885 | Cuff Resting Diameter,28.6,MM;Inner Diameter,8.5,MM;Distal Length (A),97,MM;Proximal Length 1 (B),117,MM | In distribution |
| 86241 | Outer Diameter 8.8 mm | In distribution |
| 18760 | Outer Diameter 8.2 mm | In distribution |
| 96365 | Cuff Resting Diameter,20.6, MM; | In distribution |
| 86111 | Outer Diameter 7.0 mm | In distribution |
| 86551 | Cuff Resting Diameter, 26.0, MM; | In distribution |
| 86109 | Outer Diameter 6.0 mm | In distribution |
| 86238 | Outer Diameter 6.8 mm | In distribution |
| 18790S | Outer Diameter 12.1 mm | In distribution |
| 18785S | Outer Diameter 11.4 mm | In distribution |
| 76255 | Outer Diameter 5.5 mm | In distribution |
| 87475 | Cuff Resting Diameter,28.7,mm;Inner Diameter,7.5,mm;Distal Length (A),89,mm;Proximal Length (B),110,mm;Proximal Length (C),64,mm | In distribution |
| 86402 | Outer Diameter 4.0 mm | In distribution |
| 86125 | Cuff Resting,8.0,mm;Inner Diameter,2.5,mm;Distal Length (A),NA,mm;Proximal Length 1 (B);27,mm;Proximal Length 2 (C),32,mm | In distribution |
| 18860S | Outer Diameter 9.0 mm | In distribution |
| 86450 | Outer Diameter 7.0 mm | In distribution |
| 86052 | Outer Diameter 7.5 mm | In distribution |
| 86454 | Outer Diameter 9.0 mm | In distribution |
| 18765 | Outer Diameter 8.9 mm | In distribution |
| 109865 | Outer Diameter 6.5 mm | In distribution |
| 86015 | Outer Diameter 9.0 mm | In distribution |
| 86202 | Outer Diameter 6.0 mm | In distribution |
| 86200 | Outer Diameter 5.0 mm | In distribution |
| 87450 | Outer Diameter 6.0 mm | In distribution |
| 86045 | Outer Diameter 4.0 mm | In distribution |
| 86108 | Outer Diameter 5.5 mm | In distribution |
| 76290 | Outer Diameter 9.0 mm | In distribution |
| 87495 | Cuff Resting Diameter,35.1,mm;Inner Diameter,9.5,mm;Distal Length (A),101,mm;Proximal Length (B),122,mm;Proximal Length (C),76,mm | In distribution |
| 86046 | Outer Diameter 4.5 mm | In distribution |
| 86401 | Outer Diameter 3.5 mm | In distribution |
| 110885 | Outer Diameter 8.5 mm | In distribution |
| 86205 | Outer Diameter 7.5 mm | In distribution |
| 86242 | Outer Diameter 9.5 mm | In distribution |
| 96560 | Outer Diameter 6.0 mm | In distribution |
| 86543 | Outer Diameter 3.5 mm | In distribution |
| 86229 | Inner Diameter, 6.0, MM; Outer Diameter, 8.2, MM; | In distribution |
| 86397 | Outer Diameter 4.5 mm | In distribution |
| 86451 | Outer Diameter 7.5 mm | In distribution |
| 86264 | Outer Diameter 3.5 mm | In distribution |
| 18860 | Cuff Resting Diameter,20.6,MM;Inner Diameter,6.0,MM;Distal Length (A),80,MM;Proximal Length 1 (B),100,MM | In distribution |
| 86206 | Outer Diameter 8.0 mm | In distribution |
| 86267 | Outer Diameter 5.0 mm | In distribution |
| 109885 | Outer Diameter 8.5 mm | In distribution |
| 18770S | Outer Diameter 9.5 mm | In distribution |
| 18880 | Cuff Resting Diameter, 25.4, MM; Inner Diameter, 8.0, MM; Outer Diameter, 11.8, MM; | In distribution |
| 18870S | Outer Diameter 10.4 mm | In distribution |
| 86389 | Outer Diameter 6.0 mm | In distribution |
| 18775 | Outer Diameter 10.2 mm | In distribution |
| 86385 | Outer Diameter 4.0 mm | In distribution |
| 87410 | Outer Diameter 13.5 mm | In distribution |
| 18795 | Outer Diameter 12.8 mm | In distribution |
| 86398 | Outer Diameter 6.0 mm | In distribution |
| 110865 | Cuff Resting Diameter,22.0,Millimeter; | In distribution |
| 86050 | Outer Diameter 6.5 mm | In distribution |
| 86135 | Cuff Resting,10.1,mm;Inner Diameter,3.5,mm;Distal Length (A),22,mm;Proximal Length 1 (B),34,mm;Proximal Length 2 (C),44,mm | In distribution |
| 86549 | Cuff Resting Diameter, 22.0, MM; | In distribution |
| 18890S | Outer Diameter 13.1 mm | In distribution |
| 86012 | Outer Diameter 7.5 mm | In distribution |
| 110875 | Outer Diameter 7.5 mm | In distribution |
| 86453 | Outer Diameter 8.5 mm | In distribution |
| 18875 | Cuff Resting Diameter, 25.4, MM; Inner Diameter, 7.5, MM; Outer Diameter, 11.2, MM; | In distribution |
| 86443 | Outer Diameter 3.5 mm | In distribution |
| 18775S | Outer Diameter 10.2 mm | In distribution |
| 86268 | Outer Diameter 5.5 mm | In distribution |
| 86541 | Outer Diameter 2.5 mm | In distribution |
| 18750S | Outer Diameter 6.9 mm | In distribution |
| 87435 | Cuff Resting Diameter,9.6,mm;Inner Diameter,3.5,mm;Distal Length (A),50,mm;Proximal Length (B),62,mm;Proximal Length (C),27,mm | In distribution |
| 85589 | Outer Diameter 6.5 mm | In distribution |
| 86232 | Outer Diameter 2.9 mm | In distribution |
| 96375 | Outer Diameter 7.5 mm | In distribution |
| 18790 | Outer Diameter 12.1 mm | In distribution |
| 86287 | End of First Ring, 33, MM; End of Second Ring, 45, MM; End of Third Ring, 57, MM; | In distribution |
| 86394 | Outer Diameter 5.0 mm | In distribution |
| 86349 | Outer Diameter 6.0 mm | In distribution |
| 86552 | Cuff Resting Diameter, 28.0, MM; | In distribution |
| 86231 | Inner Diameter, 7.0, MM; Outer Diameter, 9.5, MM; | In distribution |
| 18770 | Outer Diameter 9.5 mm | In distribution |
| 85592 | Outer Diameter 8.0 mm | In distribution |
| 18865 | Cuff Resting Diameter,20.6,MM;Inner Diameter,6.5,MM;Distal Length (A),94,MM;Proximal Length 1 (B),104,MM | In distribution |
| 76270 | Outer Diameter 7.0 mm | In distribution |
| 86199 | Outer Diameter 4.5 mm | In distribution |
| 86266 | Outer Diameter 4.5 mm | In distribution |
| 86110 | Outer Diameter 6.5 mm | In distribution |
| 87460 | Outer Diameter 8.2 mm | In distribution |
| 86442 | Outer Diameter 3.0 mm | In distribution |
| 86548 | In distribution | |
| 86268 | Outer Diameter 5.5 mm | In distribution |
| 96380 | Outer Diameter 8.0 mm | In distribution |
| 96370 | Inner Diameter, 7.0, MM; Outer Diameter, 9.4, MM; Cuff Resting Diameter, 25.4, MM; | In distribution |
| 18890 | Cuff Resting Diameter,28.6,MM;Inner Diameter,9.0,MM;Distal Length (A),100,MM;Proximal Length 1 (B),120,MM | In distribution |
| 87480 | Outer Diameter 10.8 mm | In distribution |
| 86203 | Outer Diameter 6.5 mm | In distribution |
| 18885S | Outer Diameter 12.6 mm | In distribution |
| 87465 | Cuff Resting Diameter,24.7,mm;Inner Diameter,6.5,mm;Distal Length (A),82,mm;Proximal Length (B),103,mm;Proximal Length (C),57,mm | In distribution |
| 18870 | Cuff Resting Diameter, 25.4, MM; Inner Diameter, 7.0, MM; Outer Diameter, 10.4, MM; | In distribution |
| 18765S | Outer Diameter 8.9 mm | In distribution |
| 86446 | Outer Diameter 5.0 mm | In distribution |
| 87490 | Cuff Resting Diameter,34.0,mm;Inner Diameter,9.0,mm;Distal Length (A),98,mm;Proximal Length (B),119,mm;Proximal Length (C),73,mm | In distribution |
| 86456 | Outer Diameter 10.0 mm | In distribution |
| 18875 | Cuff Resting Diameter,25.4,MM;Inner Diameter,7.5,MM;Distal Length (A),91,MM;Proximal Length 1 (B),111,MM | In distribution |
| 86550 | Outer Diameter 7.0 mm | In distribution |
| 86287 | Outer Diameter 5.0 mm | In distribution |
| 86387 | Outer Diameter 5.0 mm | In distribution |
| 18865S | Outer Diameter 9.8 mm | In distribution |
| 86130 | Cuff Resting,9.1,mm;Inner Diameter,3.0,mm;Distal Length (A),19,mm;Proximal Length 1 (B),29,mm;Proximal Length 2 (C),38,mm | In distribution |
| 86266 | End of First Ring, 31, MM; End of Second Ring, 43, MM; End of Third Ring, 55, MM; | In distribution |
| 86264 | End of First Ring, 27, MM; End of Second Ring, 39, MM; End of Third Ring, 51, MM; | In distribution |
| 86545 | Outer Diameter 4.5 mm | In distribution |
| 86115 | Outer Diameter 12.1 mm | In distribution |
| 86263 | Outer Diameter 3.0 mm | Withdrawn |
| 86007 | Outer Diameter 5.0 mm | Withdrawn |
| 96585 | Cuff Resting Diameter, 28.6, MM; | Withdrawn |
| 86653 | Outer Diameter 3.0 mm | Withdrawn |
| 86466 | Outer Diameter 5.0 mm | Withdrawn |
| 86460 | Inner Diameter, 2.0, MM; Outer Diameter, 3.0, MM; | Withdrawn |
| 86054 | Outer Diameter 8.5 mm | Withdrawn |
| 86225 | Inner Diameter, 4.0, MM; Outer Diameter, 5.6, MM; | Withdrawn |
| 86289 | Outer Diameter 6.0 mm | Withdrawn |
| 86285 | Outer Diameter 4.0 mm | Withdrawn |
| 86270 | End of First Ring, 40, MM; End of Second Ring, 52, MM; End of Third Ring, 64, MM; | Withdrawn |
| 96590 | Cuff Resting Diameter, 28.6, MM; | Withdrawn |
| 86223 | Inner Diameter, 3.0, MM; Outer Diameter, 4.3, MM; | Withdrawn |
| 86652 | Outer Diameter 2.5 mm | Withdrawn |
| 86208 | Outer Diameter 9.0 mm | Withdrawn |
| 96570 | Cuff Resting Diameter, 25.4, MM; | Withdrawn |
| 86645 | Outer Diameter 4.0 mm | Withdrawn |
| 86222 | Inner Diameter, 2.5, MM; Outer Diameter, 3.6, MM; | Withdrawn |
| 86056 | Outer Diameter 9.5 mm | Withdrawn |
| 86355 | Outer Diameter 9.0 mm | Withdrawn |
| 86643 | Outer Diameter 3.0 mm | Withdrawn |
| 86648 | Outer Diameter 5.5 mm | Withdrawn |
| 86644 | Outer Diameter 3.5 mm | Withdrawn |
| 96575 | Cuff Resting Diameter, 25.4, MM; | Withdrawn |
| 86467 | Outer Diameter 5.5 mm | Withdrawn |
| 86016 | Outer Diameter 9.5 mm | Withdrawn |
| 86043 | Outer Diameter 3.0 mm | Withdrawn |
| 109850 | Cuff Resting Diameter, 20.0,Millimeter; | Withdrawn |
| 86010 | Outer Diameter 6.5 mm | Withdrawn |
| 109855 | Outer Diameter 5.5 mm | Withdrawn |
| 85588 | Outer Diameter 6.0 mm | Withdrawn |
| 86224 | Inner Diameter, 3.5, MM; Outer Diameter, 4.9, MM; | Withdrawn |
| 86269 | Outer Diameter 6.0 mm | Withdrawn |
Showing 250 of 295 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2023-02-10 | Class II | Process control | Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. | 12,310 devices | |
| Stryker Sustainability Solutions | 510(k) number | 2016-04-04 | Class II | Process control | Device packaging may not be sealed. | 4 | 2016-07-13 |
| Stryker Sustainability Solutions | 510(k) number | 2016-04-04 | Class II | Process control | Device packaging may not be sealed. | 2 | 2016-07-13 |
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.