| Primary Device ID | 10841470106215 |
| NIH Device Record Key | abd10942-59c3-428f-8709-7d30bcc88ebb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ABC -Flex Tube System |
| Version Model Number | F060323M3X1E4 |
| Company DUNS | 154502934 |
| Company Name | ENGINEERED MEDICAL SYSTEMS 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470106218 [Primary] |
| GS1 | 10841470106215 [Package] Contains: 00841470106218 Package: [10 Units] In Commercial Distribution |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-21 |
| Device Publish Date | 2025-04-11 |
| 10841470106215 - ABC -Flex Tube System | 2025-04-21 |
| 10841470106215 - ABC -Flex Tube System | 2025-04-21 |
| 10841470106260 - ABC - Uniflow Breathing Circuit | 2025-04-21 |
| 10841470106284 - ABC - Duoflow Bi-lumen Breathing Circuit | 2025-04-21 |
| 10841470106345 - ABC - Flex Tube System | 2025-04-21 |
| 10841470106574 - ABC - Compact Breathing Circuit | 2025-04-21 |
| 10841470106581 - ABC - Compact Breathing Circuit | 2025-04-21 |
| 10841470106734 - ABC - Duoflow Bi-lumen Breathing Circuit | 2025-04-21 |
| 10841470107113 - ABC - Uniflow Breathing Circuit | 2025-04-21 |