| Primary Device ID | 50628725050053 |
| NIH Device Record Key | 7b671ba4-3067-4a0b-b7c2-14d004d80a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epidural Anesthesia Kit |
| Version Model Number | CPT4 |
| Catalog Number | CPT4 |
| Company DUNS | 118995594 |
| Company Name | CHS USA 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 | true |
| 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 | 00628725050058 [Primary] |
| GS1 | 50628725050053 [Package] Contains: 00628725050058 Package: [30 Units] In Commercial Distribution |
| OGE | Epidural Anesthesia Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
[50628725050053]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 50628725050060 | SINGLE SHOT EPIDURAL TRAY |
| 50628725050053 | Needle Stick Pad, Syringe, Luer Lock, needle, L.O.R. Syringe, Drape, adhesive fen, Towel, PVP Tr |
| 50628725050046 | Needle Stick Pad, Syringe, 3cc and 5 cc LL, 1 - LIDOCAINEHCL - 1_5ML Lidocaine, 1%, 5ml Glass Am |