| Primary Device ID | 00685447018414 |
| NIH Device Record Key | 71d916d2-d550-4b87-9c21-2a1fac717f8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NRG Large Access Solution |
| Version Model Number | NLK71-C0-125-67 |
| Company DUNS | 249225954 |
| Company Name | Baylis Médicale Cie Inc |
| 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 | 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00685447018414 [Primary] |
| DXF | Catheter, Septostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 00685447004837 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447004820 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447004813 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447004806 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447004790 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447004783 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005872 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005865 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005858 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005841 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005834 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447005827 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015352 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015345 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015338 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015321 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015314 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015307 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015291 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015284 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015277 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015260 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015253 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447015246 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018469 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018452 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018445 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018438 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018421 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |
| 00685447018414 | 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip |