Shiley 8FEN
GUDID 50884522007038
Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated
Covidien LP
Basic tracheostomy tube, single-use| Primary Device ID | 50884522007038 |
| NIH Device Record Key | 3c3f1f57-26e1-4e04-bb8c-2ab35d552314 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shiley |
| Version Model Number | 8FEN |
| Catalog Number | 8FEN |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
| Device Size Text, specify | 0 |
| Length | 81 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 50884522007038 [Package] Contains: 60884522007035 Package: CASE [108 Units] In Commercial Distribution |
| GS1 | 60884522007035 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K962173
FDA Product Code
| JOH | Tube tracheostomy and tube cuff |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2015-08-31 |
On-Brand Devices [Shiley]
| 70884522007575 | TaperGuard Oral/Nasal Tracheal Tube,Murphy Eye |
| 80884522011593 | CPAP System For Dual Lumen Tracheal Tube |
| 50884522029207 | Tracheal Tube Cuffless Reinforced |
| 40884522029194 | Tracheal Tube Cuffless Reinforced |
| 40884522029187 | Tracheal Tube Cuffless Reinforced |
| 50884522029177 | Tracheal Tube Cuffless Reinforced |
| 50884522029160 | Tracheal Tube Cuffless Reinforced |
| 40884522029156 | Tracheal Tube Cuffless Reinforced |
| 40884522029149 | Tracheal Tube Cuffless Reinforced |
| 50884522007533 | TaperGuard Oral/Nasal Tracheal Tube,Murphy Eye |
| 30884522007140 | Tracheostomy Tube Cuffed with Inner Cannula |
| 50884522007137 | Tracheostomy Tube Cuffed with Inner Cannula |
| 50884522007120 | Tracheostomy Tube Cuffed with Inner Cannula |
| 50884522007113 | Tracheostomy Tube Cuffed with Inner Cannula |
| 50884522007038 | Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated |
| 50884522007021 | Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated |
| 50884522006987 | Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated |
| 50884522006970 | Tracheostomy Tube Cuffless with Inner Cannula |
| 50884522006963 | Tracheostomy Tube Cuffless with Inner Cannula |
| 50884522006956 | Tracheostomy Tube Cuffless with Inner Cannula |
| 40884522006942 | Tracheostomy Tube Cuffless with Inner Cannula |
| 50884522006734 | Inner Cannula XLT,Disposable |
| 50884522006727 | Inner Cannula XLT,Disposable |
| 40884522006713 | Inner Cannula XLT,Disposable |
| 30884522006501 | Nasal RAE Tracheal Tube Cuffless,Murphy Eye |
| 70884522005359 | Cap |
| 50884522005331 | Inner Cannula,Fenestrated, Disposable |
| 40884522005327 | Inner Cannula,Disposable |
| 40884522005297 | Inner Cannula,Fenestrated, Disposable |
| 50884522005287 | Inner Cannula,Disposable |
| 40884522005259 | Inner Cannula,Fenestrated, Disposable |
| 50884522005249 | Inner Cannula,Disposable |
| 50884522005218 | Inner Cannula,Fenestrated, Disposable |
| 50884522005201 | Inner Cannula,Disposable |
| 10884522004053 | Oral RAE Tracheal Tube Cuffed,Murphy Eye |
| 20884522000786 | Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye |
| 30884522000165 | Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Murphy Eye |
| 40884521133137 | Nasopharyngeal Airway |
| 40884521133120 | Nasopharyngeal Airway |
| 50884521133110 | Nasopharyngeal Airway |
| 50884521133103 | Nasopharyngeal Airway |
| 40884521133083 | Nasopharyngeal Airway |
| 40884521133076 | Nasopharyngeal Airway |
| 60884522007721 | Speaking Valve |
| 60884522007103 | Laryngectomy Tube |
| 60884522007097 | Laryngectomy Tube |
| 60884522007080 | Laryngectomy Tube |
| 40884522007017 | Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated |
| 60884522006939 | Tracheostomy Tube Cuffless with Inner Cannula,Fenestrated |
| 60884522006915 | Tracheostomy Tube Cuffless with Inner Cannula,Fenestrated |
Trademark Results [Shiley]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHILEY 87453058 5667132 Live/Registered |
Covidien LP 2017-05-17 |
 SHILEY 73109823 1107132 Live/Registered |
SHILEY LABORATORIES, INC. 1976-12-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.