| Primary Device ID | 00817395024401 |
| NIH Device Record Key | b7141e37-e456-432f-aedd-702fbf5c5567 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEGA Lithotomy RFID Pack |
| Version Model Number | NG115RFA |
| Company DUNS | 015179820 |
| Company Name | PACKROOM LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | false |
| 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 | 00817395024401 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-02 |
| Device Publish Date | 2026-02-20 |
| 00817395024401 - NEGA Lithotomy RFID Pack | 2026-03-02NEGA Lithotomy RFID Pack |
| 00817395024401 - NEGA Lithotomy RFID Pack | 2026-03-02 NEGA Lithotomy RFID Pack |
| 00817395024364 - Pack, Angio Hamilton | 2025-09-11 Pack, Angio Hamilton |
| 00817395024357 - Kennestone Upper Extremity Pack | 2025-09-10 Kennestone Upper Extremity Pack |
| 00817395024203 - Pack, Basic NEGA *RFID | 2025-04-17 Pack, Basic NEGA *RFID |
| 00817395024067 - Kit, Kennestone Permacath | 2024-07-03 Kit, Kennestone Permacath |
| 00817395024074 - Kit, Sub Extremity NEGA | 2024-07-03 Kit, Sub Extremity NEGA |
| 00817395024081 - Kit, Ped Intub Blue 19-23kg NGHS | 2024-07-03 Kit, Ped Intub Blue 19-23kg NGHS |
| 00817395024098 - Kit, Ped Nurse Blue 19-23kg NGHS | 2024-07-03 Kit, Ped Nurse Blue 19-23kg NGHS |