Primary Device ID | 00817395023824 |
NIH Device Record Key | dee8483c-3aba-49d2-8f33-cf49c9bd4329 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NEGA Open Heart *RFID PB |
Version Model Number | CDS840132RFPBO |
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 | 00817395023824 [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 | 2024-03-27 |
Device Publish Date | 2024-03-19 |
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 |
00817395024111 - Kit, Ped Nurse Green 30-36kg NGHS | 2024-07-03 Kit, Ped Nurse Green 30-36kg NGHS |
00817395024128 - Kit, Ped Intub Orange 24-29kg NGHS | 2024-07-03 Kit, Ped Intub Orange 24-29kg NGHS |