| Primary Device ID | 00842071113643 |
| NIH Device Record Key | f708a17c-d96b-4815-aa50-79fdc9eb5030 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMT Y-Port Accessory |
| Version Model Number | E4-0005-ISOSAF |
| Catalog Number | E4-0005-ISOSAF, 4-0005-ISOSAF |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, 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 | 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 | |
| Phone | (440) 717-4000 |
| cs@appliedmedical.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071113629 [Primary] |
| GS1 | 00842071113643 [Package] Contains: 00842071113629 Package: Box (4-0005-ISOSAF) [10 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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 00842071113643 | Dual ENFit Y-Port Accessory (Single Female Enfit to Dual Male Enfit) |
| 00842071113636 | Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port) |