| Primary Device ID | B875500 |
| NIH Device Record Key | 09bbdcf7-0c4f-4916-bf85-b1290d281504 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Refill Tray |
| Version Model Number | 50 |
| Catalog Number | 50 |
| Company DUNS | 030406006 |
| Company Name | Custom Interventional Pain Management, LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B875500 [Primary] |
| OGE | Epidural Anesthesia Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
[B875500]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| B875700 - Individual Ancillary Item Kit | 2023-09-19 Convenience kit non-medicated |
| B87560LID0 - Discseel | 2023-08-23 Convenience kit with Lidocaine |
| B875DSCLID0 - Discseel | 2023-08-23 Convenience kit with Lidocaine |
| B875170 - Epidural Anesthesia Kit | 2023-07-27 Convenience kit no Lidocaine |
| B87517LID0 - Epidural Anesthesia Kit | 2023-07-27 Convenience kit with Lidocaine |
| B875180 - Epidural Anesthesia Kit | 2023-07-27 Convenience kit no Lidocaine |
| B87518LID0 - Epidural Anesthesia Kit | 2023-07-27 Convenience kit with Lidocaine |
| B875200 - Epidural Anesthesia Kit | 2023-07-27 Convenience kit no Lidocaine |