| Primary Device ID | 00817395023015 |
| NIH Device Record Key | 681f2280-92e3-4c36-8766-f60aac76baae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kennestone Cardiovascular |
| Version Model Number | WK350A |
| 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 | 00817395023015 [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 | 2022-04-12 |
| Device Publish Date | 2022-04-04 |
| 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 |
| 00817395024104 - Kit, Ped Intub Green 30-36kg NGHS | 2024-07-03 Kit, Ped Intub Green 30-36kg NGHS |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KENNESTONE CARDIOVASCULAR 78412163 2964104 Dead/Cancelled |
Kennestone Cardiovascular Consultants, P.C. 2004-05-03 |