| Primary Device ID | 04046964943232 |
| NIH Device Record Key | b3325465-8946-4185-9777-98c73570c5a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 339169 |
| Catalog Number | 339169 |
| Company DUNS | 002397347 |
| Company Name | B. BRAUN MEDICAL INC. |
| Device Count | 100 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046961020790 [Primary] |
| GS1 | 04046964943232 [Unit of Use] |
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-10 |
| Device Publish Date | 2025-12-02 |
| 04045928020866 - Design Options® | 2026-02-11 CESK CONTINUOUS EPIDURAL TRAY 2 |
| 04046955900534 - Perifix® | 2026-02-11 Continuous Epidural Tray |
| 04046955900855 - Design Options® | 2026-02-11 Continuous Epidural Tray |
| 04046955901197 - Combined Spinal & Epidural | 2026-02-11 Combined Spinal/Epidural Tray |
| 04045928020200 - Design Options® | 2026-02-09 SESK COMBINED SPINAL AND EPIDURAL TRAY 2 |
| 04046955966165 - Design Options® | 2026-02-02 MEMORIAL HERMANN TMC- NERVE BLOCK TRAY |
| 04046955086832 - Extension Set | 2026-01-29 EXTENSION SET, 47 IN. |
| 04046964296710 - Extension Set | 2026-01-29 ANESTHESIA SET W/ SAFEPORT MANIFOLD |