Primary Device ID | B739605000041100 |
NIH Device Record Key | bce4ad81-e367-4636-bf55-90e351551ed2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 6050-0004-110 |
Version Model Number | 6050-0004-110 |
Company DUNS | 330943838 |
Company Name | EnviteC-Wismar GmbH |
Device Count | 1 |
DM Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +493841360324 |
Christian.Walsleben@honeywell.com |
Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B739605000041100 [Primary] |
CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2019-04-09 |
04036616010900 - Oxygen Sensor | 2022-06-27 Oxygen Sensor OOMLF204 |
04036616000581 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2221-1 BCI |
04036616000604 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2251-1 Datex |
04036616005494 - Disposable Sensor | 2021-11-10 Disposabel Sensor DA-2211-1 Nellcor |
04036616005982 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2231-1 Nonin |
04036616007146 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2221-1 OEM BCI |
04036616007214 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2231-1 OEM Nonin |
04036616007528 - Disposable Sensor | 2021-11-10 Disposable Sensor DA-2211-1 OEM Nellcor |