Spectrum IQ 3570009
GUDID 00085412610900
The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
BAXTER INTERNATIONAL INC.
General-purpose infusion pump, line-powered Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel| Primary Device ID | 00085412610900 |
| NIH Device Record Key | d161f6ff-ce37-499e-882a-c8c6dc30a53c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectrum IQ |
| Version Model Number | 3570009 |
| Catalog Number | 3570009 |
| Company DUNS | 079209157 |
| Company Name | BAXTER INTERNATIONAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412610900 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173084
FDA Product Code
| PHC | Infusion safety management software |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-31 |
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Trademark Results [Spectrum IQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRUM IQ 87062637 5722670 Live/Registered |
BAXTER INTERNATIONAL INC. 2016-06-07 |
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