CMExpress® Pump Pole Mount Charger

GUDID B101150386X0

CME AMERICA LLC

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 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	B101150386X0
NIH Device Record Key	92abb776-aec5-4279-94f3-c292d1e7b271
Commercial Distribution Status	In Commercial Distribution
Brand Name	CMExpress® Pump Pole Mount Charger
Version Model Number	150-386X
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	false
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
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx
Phone	303-936-4945
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B101150386X0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042696

FDA Product Code

MEA	Pump, Infusion, Pca

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	2016-09-16

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