| Primary Device ID | 00842071115937 |
| NIH Device Record Key | 8606a6f6-1a84-48ba-b321-45d09b333409 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMT Bridle™ Pro |
| Version Model Number | E4-421618 |
| Catalog Number | E4-421618, 4-421618 |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (440) 717-4000 |
| cs@appliedmedical.net |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071115890 [Primary] |
| GS1 | 00842071115937 [Package] Contains: 00842071115890 Package: Box (4-421618) [5 Units] In Commercial Distribution |
| KNT | Tubes, Gastrointestinal (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-12-30 |
| 00842071115937 | 16 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched) |
| 00842071115920 | 12 - 14 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched) |
| 00842071115913 | 8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched) |
| 00842071115906 | 5 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched) |