CMExpress® Pump
GUDID B101100500PX0
Pump, battery 1800mAh, pole mount charger, power cord, Operator's Manual
CME AMERICA LLC
General-purpose infusion pump, line-powered| Primary Device ID | B101100500PX0 |
| NIH Device Record Key | dc4d81e5-78c2-4adb-b397-81d434fed074 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CMExpress® Pump |
| Version Model Number | 100-500PX |
| Company DUNS | 002125419 |
| Company Name | CME AMERICA LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx | |
| Phone | 303-936-4945 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B101100500PX0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042696
FDA Product Code
| FRN | Pump, Infusion |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [CMExpress® Pump]
| B101100500PXA0 | Pump, 9-Volt Battery Pack, Operator's Manual |
| B101100500PX0 | Pump, battery 1800mAh, pole mount charger, power cord, Operator's Manual |
Trademark Results [CMExpress]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CMEXPRESS 77676478 3759088 Live/Registered |
CME America, LLC 2009-02-23 |
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