T34 Syringe Pump System

GUDID B101100100PSA0

Pump, Operator's Manual

CME AMERICA LLC

General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic
Primary Device IDB101100100PSA0
NIH Device Record Keya3e5fd23-33cc-4726-977d-bcde99d07e83
Commercial Distribution StatusIn Commercial Distribution
Brand NameT34 Syringe Pump System
Version Model Number100-100PSA
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB101100100PSA0 [Primary]

FDA Product Code

MEAPump, Infusion, Pca

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-03
Device Publish Date2016-09-15

On-Brand Devices [T34 Syringe Pump System]

B101100100PSA0Pump, Operator's Manual
B101100100POBSC0Pump, Operator's Manual

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