Pilling
CJ Trachea Tube Original #8 W/15 Millimeter Adapto
1manufacturer
248catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-03 |
| Record revised | 2024-01-11 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 34 to 88 mm; length 3.5 to 7 cm; outer diameter 4.5 to 16.3 mm; length 0.625 to 1.125 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN008222 | Length 63 mm | In distribution |
| IPN900860 | In distribution | |
| IPN008207 | Length 7 cm | In distribution |
| IPN008356 | Length 70 mm | In distribution |
| IPN008318 | Outer Diameter 8 mm | In distribution |
| IPN012593 | In distribution | |
| IPN008317 | Length 6 cm | In distribution |
| IPN008356 | Length 70 mm | In distribution |
| IPN008221 | Length 61 mm | In distribution |
| IPN008349 | Length 70 mm | In distribution |
| IPN008304 | Length 7 cm | In distribution |
| IPN008341 | Length 57 mm | In distribution |
| IPN008315 | Length 3.5 cm | In distribution |
| IPN008324 | Outer Diameter 11 mm | In distribution |
| IPN008355 | Length 70 mm | In distribution |
| IPN900863 | In distribution | |
| IPN008345 | Length 53 mm | In distribution |
| IPN008500 | Length 0.625 in | In distribution |
| IPN008289 | Outer Diameter 7 mm | In distribution |
| IPN008329 | Outer Diameter 14 mm | In distribution |
| IPN008282 | Length 43 mm | In distribution |
| IPN008211 | Length 7 cm | In distribution |
| IPN008224 | Length 63 mm | In distribution |
| IPN008330 | Length 5 cm | In distribution |
| IPN008364 | Length 53 mm | In distribution |
| IPN008289 | Length 6 cm | In distribution |
| IPN008369 | Length 88 mm | In distribution |
| IPN008219 | Length 61 mm | In distribution |
| IPN008350 | Length 70 mm | In distribution |
| IPN008279 | Length 50 mm | In distribution |
| IPN008375 | Length 59 mm | In distribution |
| IPN008219 | Length 61 mm | In distribution |
| IPN008290 | Length 6.5 cm | In distribution |
| IPN008241 | Length 0.75 in | In distribution |
| IPN008230 | Outer Diameter 10 mm | In distribution |
| IPN008309 | Length 7 cm | In distribution |
| IPN008196 | 6.1MM I.D.,9.0MM O.D. | In distribution |
| IPN008299 | Length 7 cm | In distribution |
| IPN008330 | Length 5 cm | In distribution |
| IPN900867 | In distribution | |
| IPN008237 | Length 63 mm | In distribution |
| IPN008360 | Length 57 mm | In distribution |
| IPN008367 | Length 88 mm | In distribution |
| IPN008368 | Length 88 mm | In distribution |
| IPN008351 | Length 59 mm | In distribution |
| IPN008352 | Length 63 mm | In distribution |
| IPN008359 | Length 57 mm | In distribution |
| IPN008358 | Length 53 mm | In distribution |
| IPN911413 | In distribution | |
| IPN008308 | Length 70 mm | In distribution |
| IPN008342 | Length 57 mm | In distribution |
| IPN008354 | Length 70 mm | In distribution |
| IPN008308 | Length 70 mm | In distribution |
| IPN008324 | Outer Diameter 11 mm | In distribution |
| IPN008203 | Length 7 cm | In distribution |
| IPN008373 | Length 45 mm | In distribution |
| IPN008212 | Length 72 mm | In distribution |
| IPN008350 | Length 70 mm | In distribution |
| IPN008333 | Length 57 mm | In distribution |
| IPN008331 | Length 53 mm | In distribution |
| IPN008303 | Length 7 cm | In distribution |
| IPN008335 | Length 57 mm | In distribution |
| IPN008300 | Length 7 cm | In distribution |
| IPN008338 | Outer Diameter 7 mm | In distribution |
| IPN900865 | In distribution | |
| IPN008366 | Length 85 mm | In distribution |
| IPN008359 | Length 57 mm | In distribution |
| IPN008327 | Length 70 mm | In distribution |
| IPN008222 | Length 63 mm | In distribution |
| IPN008372 | Length 39 mm | In distribution |
| IPN008362 | Length 57 mm | In distribution |
| IPN900877 | In distribution | |
| IPN008377 | Length 69 mm | In distribution |
| IPN008348 | Length 70 mm | In distribution |
| IPN008374 | Length 52 mm | In distribution |
| IPN025281 | In distribution | |
| IPN008229 | Length 5.5 cm | In distribution |
| IPN008287 | Length 4.5 cm | In distribution |
| IPN008328 | Length 7 cm | In distribution |
| IPN008366 | Length 85 mm | In distribution |
| IPN008354 | Length 70 mm | In distribution |
| IPN008196 | Length 7 cm | In distribution |
| IPN008301 | Length 7 cm | In distribution |
| IPN008280 | Length 50 mm | In distribution |
| IPN008323 | Length 70 mm | In distribution |
| IPN008318 | Outer Diameter 8 mm | In distribution |
| IPN008311 | Length 7 cm | In distribution |
| IPN008304 | 7.2MM I.D.,10.0MM O.D. | In distribution |
| IPN008352 | Length 63 mm | In distribution |
| IPN008331 | Length 53 mm | In distribution |
| IPN008224 | Length 63 mm | In distribution |
| IPN008338 | Length 5 cm | In distribution |
| IPN008348 | Length 70 mm | In distribution |
| IPN008370 | Length 88 mm | In distribution |
| IPN008230 | Length 5.5 cm | In distribution |
| IPN008201 | Length 7 cm | In distribution |
| IPN008321 | Length 69 mm | In distribution |
| IPN008291 | Length 6.5 cm | In distribution |
| IPN008322 | Length 7 cm | In distribution |
| IPN900866 | In distribution | |
| IPN008293 | Length 63 mm | In distribution |
| IPN008364 | Length 53 mm | In distribution |
| IPN900859 | In distribution | |
| IPN008360 | Length 57 mm | In distribution |
| IPN008194 | Length 63 mm | In distribution |
| IPN008298 | Length 68 mm | In distribution |
| IPN008293 | Length 63 mm | In distribution |
| IPN008337 | Length 57 mm | In distribution |
| IPN008325 | Length 7 cm | In distribution |
| IPN008278 | Length 50 mm | In distribution |
| IPN008194 | Length 63 mm | In distribution |
| IPN008305 | Length 7 cm | In distribution |
| IPN008333 | Length 57 mm | In distribution |
| IPN900861 | In distribution | |
| IPN008296 | 6.2MM I.D.,9.0MM O.D. | In distribution |
| IPN008301 | 7.2MM I.D.,10.0MM O.D. | In distribution |
| IPN008316 | Outer Diameter 6 mm | In distribution |
| IPN900875 | In distribution | |
| IPN008335 | Length 57 mm | In distribution |
| IPN900870 | In distribution | |
| IPN008201 | 6.1MM I.D. | In distribution |
| IPN008217 | Length 56 mm | In distribution |
| IPN900880 | In distribution | |
| IPN008322 | Outer Diameter 10 mm | In distribution |
| IPN008320 | Outer Diameter 9 mm | In distribution |
| IPN008220 | Length 63 mm | In distribution |
| IPN008311 | Outer Diameter 13 mm | In distribution |
| IPN008339 | Length 5.5 cm | In distribution |
| IPN008346 | Length 70 mm | In distribution |
| IPN008232 | Outer Diameter 11 mm | In distribution |
| IPN008209 | Length 72 mm | In distribution |
| IPN008370 | Length 88 mm | In distribution |
| IPN008365 | Length 57 mm | In distribution |
| IPN008231 | Outer Diameter 10 mm | In distribution |
| IPN008218 | Length 58 mm | In distribution |
| IPN008340 | Length 57 mm | In distribution |
| IPN008334 | Length 57 mm | In distribution |
| IPN008319 | Length 63 mm | In distribution |
| IPN008225 | Length 61 mm | In distribution |
| IPN008231 | Outer Diameter 10 mm | In distribution |
| IPN900869 | In distribution | |
| IPN008212 | Length 72 mm | In distribution |
| IPN008341 | Length 57 mm | In distribution |
| IPN008306 | 8.1MM I.D.,11.0MM O.D. | In distribution |
| IPN008211 | Length 7 cm | In distribution |
| IPN008216 | Outer Diameter 10 mm | In distribution |
| IPN008226 | Length 63 mm | In distribution |
| IPN008349 | Length 70 mm | In distribution |
| IPN008323 | Length 70 mm | In distribution |
| IPN008334 | Length 57 mm | In distribution |
| IPN008295 | Length 7 cm | In distribution |
| IPN008207 | Length 7 cm | In distribution |
| IPN008281 | Length 43 mm | In distribution |
| IPN008237 | Length 63 mm | In distribution |
| IPN008218 | Length 58 mm | In distribution |
| IPN008225 | Length 61 mm | In distribution |
| IPN008353 | Length 69 mm | In distribution |
| IPN008361 | Length 57 mm | In distribution |
| IPN008239 | Length 0.75 in | In distribution |
| IPN008217 | Length 56 mm | In distribution |
| IPN008346 | Length 70 mm | In distribution |
| IPN008306 | Length 7 cm | In distribution |
| IPN008310 | Outer Diameter 12 mm | In distribution |
| IPN008287 | Outer Diameter 5.5 mm | In distribution |
| IPN008232 | Outer Diameter 11 mm | In distribution |
| IPN008361 | Length 57 mm | In distribution |
| IPN008337 | Length 57 mm | In distribution |
| IPN008240 | Length 0.75 in | In distribution |
| IPN008357 | Length 70 mm | In distribution |
| IPN008343 | Length 57 mm | In distribution |
| IPN008220 | Length 63 mm | In distribution |
| IPN008239 | Length 0.75 in | In distribution |
| IPN008353 | Length 69 mm | In distribution |
| IPN008371 | Length 34 mm | In distribution |
| IPN008291 | Length 6.5 cm | In distribution |
| IPN008369 | Length 88 mm | In distribution |
| IPN008347 | Length 70 mm | In distribution |
| IPN008339 | Outer Diameter 7 mm | In distribution |
| IPN008368 | Length 88 mm | In distribution |
| IPN008241 | Length 0.75 in | In distribution |
| IPN008332 | Length 57 mm | In distribution |
| IPN008300 | Outer Diameter 10 mm | In distribution |
| IPN008336 | Length 57 mm | In distribution |
| IPN008310 | Outer Diameter 12 mm | In distribution |
| IPN008326 | Length 70 mm | In distribution |
| IPN008298 | Length 68 mm | In distribution |
| IPN008223 | Length 61 mm | In distribution |
| IPN008365 | Length 57 mm | In distribution |
| IPN900874 | In distribution | |
| IPN008283 | Length 4.5 cm | In distribution |
| IPN008376 | Length 63 mm | In distribution |
| IPN008315 | Length 3.5 cm | In distribution |
| IPN008203 | 7.1MM I.D.,10.0MM O.D. | In distribution |
| IPN008288 | Length 5 cm | In distribution |
| IPN008336 | Length 57 mm | In distribution |
| IPN008208 | Length 70 mm | In distribution |
| IPN008347 | Length 70 mm | In distribution |
| IPN008209 | Length 72 mm | In distribution |
| IPN008216 | Length 4.5 cm | In distribution |
| IPN008340 | Length 57 mm | In distribution |
| IPN008208 | Length 70 mm | In distribution |
| IPN008367 | Length 88 mm | In distribution |
| IPN008325 | Length 7 cm | In distribution |
| IPN008351 | Length 59 mm | In distribution |
| IPN008240 | Length 0.75 in | In distribution |
| IPN900871 | In distribution | |
| IPN008312 | Outer Diameter 14 mm | In distribution |
| IPN008229 | Outer Diameter 9 mm | In distribution |
| IPN008312 | Length 7 cm | In distribution |
| IPN008294 | 5.5MM I.D.,8MM O.D. | In distribution |
| IPN008296 | Length 7 cm | In distribution |
| IPN008326 | Length 70 mm | In distribution |
| IPN008317 | Outer Diameter 7 mm | In distribution |
| IPN900862 | In distribution | |
| IPN008321 | Length 69 mm | In distribution |
| IPN008288 | Outer Diameter 6 mm | In distribution |
| IPN008303 | Outer Diameter 10 mm | In distribution |
| IPN008327 | Length 70 mm | In distribution |
| IPN008309 | Length 7 cm | In distribution |
| IPN008329 | Length 7 cm | In distribution |
| IPN900879 | In distribution | |
| IPN008362 | Length 57 mm | In distribution |
| IPN008319 | Length 63 mm | In distribution |
| IPN008320 | Outer Diameter 9 mm | In distribution |
| IPN900873 | In distribution | |
| IPN008299 | Length 7 cm | In distribution |
| IPN008328 | Length 7 cm | In distribution |
| IPN008223 | Length 61 mm | In distribution |
| IPN008295 | Length 7 cm | In distribution |
| IPN008343 | Length 57 mm | In distribution |
| IPN008294 | 5.5MM I.D.,8MM O.D. | In distribution |
| IPN900876 | In distribution | |
| IPN008305 | Outer Diameter 11 mm | In distribution |
| IPN025109 | In distribution | |
| IPN008221 | Length 61 mm | In distribution |
| IPN008332 | Length 57 mm | In distribution |
| IPN008316 | Length 5 cm | In distribution |
| IPN900878 | In distribution | |
| IPN008345 | Length 53 mm | In distribution |
| IPN900872 | In distribution | |
| IPN008342 | Length 57 mm | In distribution |
| IPN008499 | Length 1.125 in | In distribution |
| IPN008355 | Length 70 mm | In distribution |
| IPN008226 | Length 63 mm | In distribution |
| IPN008357 | Length 70 mm | In distribution |
| IPN008290 | Length 6.5 cm | In distribution |
| IPN008277 | Length 50 mm | In distribution |
| IPN008358 | Length 53 mm | In distribution |
Same Product Code
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|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Portex | ICU Medical, Inc | 380 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233713 | 2024-03-22 |
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.