SoftTip® large 1002210
GUDID 04036616010009
SoftTip® large R-3212-9 MySign® FDA
EnviteC-Wismar GmbH
Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable| Primary Device ID | 04036616010009 |
| NIH Device Record Key | 6ab6c440-d1c9-48f1-9853-c343ffeeed63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoftTip® large |
| Version Model Number | R-3212-9 MySign® FDA |
| Catalog Number | 1002210 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04036616010009 [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® large]
| 04036616010245 | SoftTip® large R-2203-16 AMC |
| 04036616010009 | SoftTip® large R-3212-9 MySign® FDA |
| 04036616009898 | SoftTip® large R-3211-12 MySign® FDA |
| 04036616009881 | SoftTip® large R-3211-31 MySign® FDA |
| 04036616005678 | SoftTip® large R-2414-30 HP/Philips |
| 04036616001854 | SoftTip® large R-2203-16 Nihon Kohden |
| 04036616001830 | SoftTip® large R-2182-3 Minolta |
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 |
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