INSPIRA AIR BC1240A
GUDID 20705031147734
INSPIRA AIR BALLOON DILATION SYSTEM 12x40
ACCLARENT, INC.
Bronchial balloon catheter| Primary Device ID | 20705031147734 |
| NIH Device Record Key | 143fe0c7-0371-4e21-9314-37810b0f64cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSPIRA AIR |
| Version Model Number | BC1240A |
| Catalog Number | BC1240A |
| Company DUNS | 361092450 |
| Company Name | ACCLARENT, INC. |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031147737 [Primary] |
| GS1 | 20705031147734 [Package] Contains: 10705031147737 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090660
FDA Product Code
| KTI | BRONCHOSCOPE ACCESSORY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2016-09-01 |
On-Brand Devices [INSPIRA AIR]
| 20705031242682 | INSPIRA AIR BALLOON DILATION SYSTEM, 8.5X24MM - 1PK |
| 20705031147710 | INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM - 1 PK |
| 20705031147703 | INSPIRA AIR BALLOON DILATION SYSTEM, 12X40MM - 1 PK |
| 20705031063171 | INSPIRA AIR BALLOON DILATION SYSTEM 14x40, 1 PK |
| 20705031063157 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK |
| 20705031063126 | INSPIRA AIR BALLOON DILATION SYSTEM 7x24, 1 PK |
| 20705031063089 | INSPIRA AIR BALLOON DILATION SYSTEM 5x24, 1 PK |
| 20705031206059 | INSPIRA AIR BALLOON DILATION SYSTEM 8.5x24 |
| 20705031147741 | INSPIRA AIR BALLOON DILATION SYSTEM 16x40 |
| 20705031147734 | INSPIRA AIR BALLOON DILATION SYSTEM 12x40 |
| 20705031132068 | INSPIRA AIR BALLOON DILATION SYSTEM 7x24 |
| 20705031131993 | INSPIRA AIR BALLOON DILATION SYSTEM 5x24 |
| 20705031063317 | INSPIRA AIR BALLOON DILATION SYSTEM 14x40 |
| 20705031063294 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40 |
Trademark Results [INSPIRA AIR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSPIRA AIR 77799114 4103460 Live/Registered |
Acclarent, Inc. 2009-08-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.