ULTRAVIEW SL 175-0646-00
GUDID 10841522122620
CABLE ASSEMBLY,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Pulse oximeter probe, reusable| Primary Device ID | 10841522122620 |
| NIH Device Record Key | c2ab81ef-83b7-440a-ba4b-b0b2b1ae4f5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTRAVIEW SL |
| Version Model Number | SUPPLY |
| Catalog Number | 175-0646-00 |
| Company DUNS | 145581588 |
| Company Name | SPACELABS HEALTHCARE (WASHINGTON), INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522122620 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103142
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 | 5 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2017-05-31 |
On-Brand Devices [ULTRAVIEW SL]
| 10841522122637 | CABLE,ASSY ADAPTER MPT/SPO2 NELL |
| 10841522122613 | CABLE ASSEMBLY,ADAPTOR,CO |
| 10841522122606 | CABLE ASSEMBLY,ADAPTOR,T1-T2 |
| 10841522122590 | CABLE ASSY, ADAPTOR, P1-P2, 91496 |
| 10841522122583 | CABLE ASSY,ADAPTOR,P1-2/P3-4,91496 |
| 10841522106439 | OPTION,SPACELABS SPO2 |
| 10841522106422 | OPTION,NELLCOR OXIMAX SPO2 |
| 10841522106415 | OPTION, MASIMO SET SPO2 |
| 10841522122620 | CABLE ASSEMBLY,SPO2 |
Trademark Results [ULTRAVIEW SL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRAVIEW SL 78408215 3143032 Live/Registered |
SPACELABS HOLDINGS, INC. 2004-04-26 |
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