| Primary Device ID | 00618874601034 |
| NIH Device Record Key | b474f200-5261-4132-9e0b-faac887c34c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CathCheck Disposable Kit (Pre-assembled) |
| Version Model Number | EPI-6010-03 |
| Company DUNS | 006891188 |
| Company Name | Milestone Scientific Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618874601034 [Primary] |
| OGE | Epidural Anesthesia Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2023-06-14 |
| 00618874601034 - CathCheck Disposable Kit (Pre-assembled) | 2023-06-22CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System |
| 00618874601034 - CathCheck Disposable Kit (Pre-assembled) | 2023-06-22 CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System |
| 00618874601102 - Epidural Disposable Kit | 2023-06-22 Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System |
| 00618874610012 - Epidural Disposable Box | 2023-06-22 Epidural Disposable Box of 10 units |
| 00618874610036 - CathCheck Disposable Kit | 2023-06-22 CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System |
| 00618874999988 - Epidural Trainer Disposable Kit | 2023-06-22 EPI 6510T CompuFlo Epidural Trainer Disposable Kit |
| 00618874999995 - CompuFlo Epidural Trainer 110V/220V | 2023-06-22 CompuFlo Epidural Trainer |
| 00618874112042 - CompuDent STA Drive Unit | 2023-06-21 STA Instrument 220V |
| 00618874116033 - CompuFlo Epidural Computer Controlled Anesthesia System | 2023-06-21 CompuFlo Epidural Computer Controlled Anesthesia System 110V |