OxiPen® 1000159
GUDID 04036616000208
OxiPen® incl. RM-3227
EnviteC-Wismar GmbH
Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter| Primary Device ID | 04036616000208 |
| NIH Device Record Key | bf011688-ab0a-4761-b9dd-d93ad27d00b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxiPen® |
| Version Model Number | incl. RM-3227 |
| Catalog Number | 1000159 |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
| Depth | 30 Millimeter |
| Height | 155 Millimeter |
| Length | 210 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04036616000208 [Primary] |
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [OxiPen®]
| 04036616000208 | OxiPen® incl. RM-3227 |
| 04036616000178 | OxiPen® incl. F-3227 |
Trademark Results [OxiPen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXIPEN 76628466 3602897 Live/Registered |
EnviteC-Wismar GmbH 2005-01-21 |
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