Bivona
GUDID 15019517241044
Smiths Medical ASD, Inc.
Tracheostomy tube, reinforced, non-customized, reusable| Primary Device ID | 15019517241044 |
| NIH Device Record Key | fd6fe0f7-4677-4cbf-99c7-da3e61629ec1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bivona |
| Version Model Number | FT20IN55NSF017N |
| Company DUNS | 082005361 |
| Company Name | Smiths Medical ASD, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15019517241044 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K923878
FDA Product Code
| JOH | Tube tracheostomy and tube cuff |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
[15019517241044]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-16 |
| Device Publish Date | 2020-09-08 |
On-Brand Devices [Bivona]
| 05021312013781 | 67FHXL90 |
| 05021312013774 | 67FHXL80 |
| 05021312013767 | 67FHXL70 |
| 05021312013750 | 67FHXL60 |
| 15019517185577 | FU19CN45NGF924N |
| 15019517185560 | HU19CS70NSC925N |
| 15019517185553 | FU19CN30NGE926N |
| 15019517185539 | FU19CN45NSC927N |
| 15019517185522 | ST19CN55NGF928N |
| 15019517185508 | FT19CN40NGE929N |
| 15019517185492 | FT19CN35NGE930N |
| 15019517185485 | SP19CN40NSC931N |
| 15019517185461 | HU19CS70NSC932N |
| 15019517185430 | FP19CN40NGE100N |
| 15019517185423 | FT16CN45NSA015N |
| 15019517185416 | FT19CN40NGA085N |
| 15019517185409 | SU18AN45NGG018N |
| 15019517185393 | FT19CN40NSA099N |
| 15019517185386 | FT19CN50NSF098N |
| 15019517185379 | FP19CN50NGA101N |
| 15019517185362 | FT19CN40NGE097N |
| 15019517185331 | FT19CN80NSC096N |
| 15019517185294 | FT19CN40NSG095N |
| 15019517185270 | SU19CN40NGF094N |
| 15019517185751 | FT19CN30NGE917N |
| 15019517185744 | FT19CN35NGE918N |
| 15019517185720 | FT19CN35NGE919N |
| 15019517185713 | FT19CN35NGE920N |
| 15019517185706 | FA19CN85NSC921N |
| 15019517185669 | SU14FN60NSC093N |
| 15019517185652 | HA19CS80ZSC112N |
| 15019517185638 | FU19CN35NSA109N |
| 15019517185621 | FT19CN30NGC111N |
| 15019517185614 | FT19CN35NGC110N |
| 15019517185607 | FT19CN40NSA108N |
| 15019517185591 | FT19CN40NGA103N |
| 15019517185584 | FT19CN40NGA102N |
| 15019517185546 | FT19CN40NGE104N |
| 15019517185515 | FT19CN40NGE107N |
| 15019517185478 | FT19CN40NGF106N |
| 15019517185454 | XT19CS45NSF105N |
| 15019517185447 | FU19CN35NGE093N |
| 15019517185935 | XT19CS80NSC905N |
| 15019517185928 | SU19CN45NSC906N |
| 15019517185911 | FT19CN70NSC908N |
| 15019517185904 | ST19CN55NSB909N |
| 15019517185898 | FT19CN30NGC910N |
| 15019517185881 | FT19CN35NGC911N |
| 15019517185874 | FT19CN50NSC912N |
| 15019517185867 | FU19CN55NSC913N |
Trademark Results [Bivona]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIVONA 85655728 4333915 Live/Registered |
Ippolito, Alessandro 2012-06-19 |
 BIVONA 76406546 2726803 Live/Registered |
SMITHS MEDICAL ASD, INC. 2002-05-13 |
 BIVONA 74023385 1655884 Dead/Cancelled |
Bivona Inc. 1990-01-29 |
 BIVONA 73735715 1563202 Dead/Cancelled |
BIVONA INC. 1988-06-21 |
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