Primary Device ID | 66900234100025 |
NIH Device Record Key | 9915f14f-33e9-461e-803e-e39b9a4eae52 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | None |
Version Model Number | S100A-090103-6 |
Company DUNS | 527945351 |
Company Name | Solaris Medical Technology, 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 | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06900234100023 [Primary] |
GS1 | 66900234100025 [Package] Contains: 06900234100023 Package: [125 Units] In Commercial Distribution |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-01-16 |
Device Publish Date | 2016-11-10 |
06900234100245 - Avante/Pacific | 2020-01-28 Philips Compatible Reusable SpO2 Adult Soft-Finger Sensor (3.0m cable) |
06900234100177 - Solairs | 2020-01-20 Nonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) |
06900234100191 - Solaris | 2020-01-20 Philips Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) |
06900234100207 - Solaris | 2020-01-17 Philips Compatible Pediatric SpO2 Soft-Finger Sensor (0.9m cable) |
66900234100025 - None | 2020-01-16Reusable Adult SpO2 Sensor for Use with Commander III device. |
66900234100025 - None | 2020-01-16 Reusable Adult SpO2 Sensor for Use with Commander III device. |
06900234100047 - Solairs | 2020-01-09 BCI Compatible Adult SpO2 Finger Sensor (0.9m cable) |
06900234100054 - Solairs | 2020-01-09 BCI Compatible Adult SpO2 Finger Sensor (3.0m cable) |
56900234100080 - Solaris | 2020-01-09 BCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) |
Mark Image Registration | Serial | Company Trademark Application Date |
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Indices Consulting LLC 2024-01-12 |