Primary Device ID | B4388100E1ST0 |
NIH Device Record Key | 0ce57679-b8df-4ed0-b71e-83792a888730 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Criticare |
Version Model Number | nGenuity 8100E1ST |
Company DUNS | 080402199 |
Company Name | CRITICARE TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
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 | B4388100E1ST0 [Primary] |
MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-16 |
Device Publish Date | 2024-07-08 |
D438506DNBUS0 | Monitor with DOX SPO2, NIBP, HR with Bluetooth |
B4388100EUS0 | nGenuity without Printer |
B4388100EPUS0 | nGenuity with Printer |
B4388100EPST0 | nGenuity with Printer and ST |
B4388100EP1US0 | nGenuity with CO2 and Printer |
B4388100EP1ST0 | nGenuity with CO2, Printer and ST |
B4388100E1US0 | nGenuity with CO2 |
B4388100E1ST0 | nGenuity with CO2 and ST |
B438560DNUS0 | Monitor with DOX SPO2, NIBP, and HR |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CRITICARE 85137614 4077882 Live/Registered |
ClearH2O, Inc. 2010-09-24 |
![]() CRITICARE 78021376 2573731 Live/Registered |
Criticare Systems, Inc. 2000-08-15 |
![]() CRITICARE 73661521 1556031 Dead/Cancelled |
CRITICAL CARE REGISTERED NURSING, INC. 1987-05-18 |