| Primary Device ID | 20817522013289 |
| NIH Device Record Key | d5c89a5e-2e25-40ee-ae2d-d006758e47d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ameritus Oral Syringe |
| Version Model Number | AEG10-KMS-BA |
| Catalog Number | AEG10-KMS-BA |
| Company DUNS | 066175613 |
| Company Name | KENTEC MEDICAL, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817522013285 [Unit of Use] |
| GS1 | 10817522013282 [Primary] |
| GS1 | 20817522013289 [Package] Contains: 10817522013282 Package: box [500 Units] In Commercial Distribution |
| GS1 | 30817522013286 [Package] Package: case [2000 Units] In Commercial Distribution |
| KYX | Dispenser, Liquid Medication |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-11 |
| Device Publish Date | 2020-06-03 |
| 20817522013296 | 20ml oral syringe |
| 20817522013289 | 10ml oral syringe |
| 20817522013272 | 5ml oral syringe |
| 20817522013265 | 3ml oral syringe |
| 20817522013258 | 1ml oral syringe |