OxiPen® 1000155
GUDID 04036616000178
OxiPen® incl. F-3227
EnviteC-Wismar GmbH
Pulse oximeter, battery-powered| Primary Device ID | 04036616000178 |
| NIH Device Record Key | b03d1918-fb2f-4fa2-8378-b065cf56acb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxiPen® |
| Version Model Number | incl. F-3227 |
| Catalog Number | 1000155 |
| 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
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 210 Millimeter |
| Height | 30 Millimeter |
| Length | 155 Millimeter |
| Width | 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 |
| 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 |
| 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 | 04036616000178 [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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.