Primary Device ID | B485CNSENV1000 |
NIH Device Record Key | 56eb7828-af02-4618-ab72-729330a1918b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CNS Envision |
Version Model Number | 1.03.00 |
Company DUNS | 874257488 |
Company Name | NATUS NEUROLOGY INCORPORATED |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 | B485CNSENV1000 [Primary] |
ORT | Burst Suppression Detection Software For Electroencephalograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-28 |
Device Publish Date | 2023-08-18 |
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00382830033688 - Natus | 2024-04-29 EDX 6 channel Amplifier |
00382830033701 - Natus | 2024-04-29 EDX 5 channel Amplifier |
00382830033725 - Natus | 2024-04-29 EDX 4 channel Amplifier |
00382830033749 - Natus | 2024-04-29 EDX 3 channel Amplifier |
00382830037266 - Natus | 2024-04-29 EDX HB7 Head Box |
00382830037273 - Natus | 2024-04-29 EDX HB6 Head Box |