Primary Device ID | 04036616000581 |
NIH Device Record Key | 0c1c01f1-288c-48e9-9b0f-87d05d235b2e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Disposable Sensor |
Version Model Number | DA-2221-1 BCI |
Catalog Number | 08-00-0123 |
Company DUNS | 330943838 |
Company Name | EnviteC-Wismar GmbH |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com | |
Phone | +493841360324 |
christian.walsleben@honeywell.com |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Height | 105 Millimeter |
Length | 155 Millimeter |
Width | 210 Millimeter |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04036616000581 [Primary] |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-11-10 |
Device Publish Date | 2016-09-22 |
04036616010238 | Disposable Sensor DN-2203-6 Nihon Kohden US |
04036616010221 | Disposable Sensor DI-2203-5 Nihon Kohden US |
04036616010214 | Disposable Sensor DP-2203-2 Nihon Kohden US |
04036616010061 | Disposable Sensor DP-2211-2 MySign® FDA |
04036616007603 | Disposable Sensor DN-2211-6 OEM Nellcor |
04036616007580 | Disposable Sensor DI-2211-5 OEM Nellcor |
04036616007559 | Disposable Sensor DP-2211-2 OEM Nellcor |
04036616007245 | Disposable Sensor DN-2231-6 OEM Nonin |
04036616007238 | Disposable Sensor DI-2231-5 OEM Nonin |
04036616007221 | Disposable Sensor DP-2231-2 OEM Nonin |
04036616007191 | Disposabel Sensor DN-2221-6 OEM BCI |
04036616007184 | Disposable Sensor DI-2221-5 OEM BCI |
04036616007160 | Disposable Sensor DP-2221-2 OEM BCI |
04036616006088 | Disposable Sensor DN-2231-6 Nonin |
04036616006071 | Disposable Sensor DI-2231-5 Nonin |
04036616006064 | Disposable Sensor DP-2231-2 Nonin |
04036616005562 | Disposable Sensor DN-2211-6P Nellcor |
04036616005524 | Disposible Sensor DN-2211-6 Nellcor |
04036616005517 | Disposable Sensor DI-2211-5 Nellcor |
04036616005500 | Disposable Sensor DP-2211-2 Nellcor |
04036616000840 | Disposable Sensor DP-2221-2 BCI |
04036616000833 | Disposable Sensor DP-2211-2P Nellcor |
04036616000758 | Disposable Sensor DN-2221-6 BCI |
04036616000666 | Disposable Sensor DI-2221-5 BCI |
04036616010207 | Disposable Sensor DA-2203-1 Nihon Kohden US |
04036616010054 | Disposable Sensor DA-2211-1 MySign® FDA |
04036616009331 | Disposable Sensor DA-2211-1L Nellcor |
04036616007528 | Disposable Sensor DA-2211-1 OEM Nellcor |
04036616007214 | Disposable Sensor DA-2231-1 OEM Nonin |
04036616007146 | Disposable Sensor DA-2221-1 OEM BCI |
04036616005982 | Disposable Sensor DA-2231-1 Nonin |
04036616005494 | Disposabel Sensor DA-2211-1 Nellcor |
04036616000604 | Disposable Sensor DA-2251-1 Datex |
04036616000581 | Disposable Sensor DA-2221-1 BCI |