SoftTip® small 1002203
GUDID 04036616009935
SoftTip® small RS-3211-12 MySign® FDA
EnviteC-Wismar GmbH
Pulse oximeter probe, reusable| Primary Device ID | 04036616009935 |
| NIH Device Record Key | 3d84a25d-6d17-4cab-8784-a76f4d1ef1a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoftTip® small |
| Version Model Number | RS-3211-12 MySign® FDA |
| Catalog Number | 1002203 |
| 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 | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
| Height | 40 Millimeter |
| Length | 140 Millimeter |
| Width | 130 Millimeter |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04036616009935 [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 | 2020-04-30 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [SoftTip® small]
| 04036616010023 | SoftTip® small RS-3212-9 MySign® FDA |
| 04036616009935 | SoftTip® small RS-3211-12 MySign® FDA |
| 04036616009928 | SoftTip® small RS-3211-31 MySign® FDA |
| 04036616009836 | SoftTip® klein RS-2414-30 HP/Philips |
Trademark Results [SoftTip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTTIP 88297860 not registered Live/Pending |
MindsInSync (Hong Kong) Ltd. 2019-02-12 |
 SOFTTIP 77451849 not registered Dead/Abandoned |
Tambrands, Inc. 2008-04-18 |
 SOFTTIP 76496019 2946500 Live/Registered |
EnviteC-Wismar GmbH 2003-03-10 |
 SOFTTIP 76353602 2836939 Live/Registered |
Blinds to Go Inc. 2001-12-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.