Manufacturing Kit CMExpress® Pump

GUDID B101100500PXE0

Pump, battery 3600mAh, tabletop charger, power cord, Operator's Manual

CME AMERICA LLC

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump 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 IDB101100500PXE0
NIH Device Record Keyb0d2018a-0cb5-48a8-9c6d-3f8488ee32bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameManufacturing Kit CMExpress® Pump
Version Model Number100-500PXE
Company DUNS002125419
Company NameCME AMERICA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx
Phone303-936-4945
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB101100500PXE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-16
Device Publish Date2020-07-08

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