Unifuser 1104X

GUDID 10841522120053

UNIFUSOR+,REUSABLE,1000mL,CUFF ONLY,EA

Statcorp Medical

Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable Intravenous pressure infusor, manual, reusable
Primary Device ID10841522120053
NIH Device Record Key8b9834ba-97da-403a-b99c-486b6acc24d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifuser
Version Model NumberUnifuser
Catalog Number1104X
Company DUNS602075905
Company NameStatcorp Medical
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522120053 [Primary]

FDA Product Code

KZDINFUSOR, PRESSURE, FOR I.V. BAGS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-10-05
Device Publish Date2017-02-22

On-Brand Devices [Unifuser]

10841522127809UNIFUSOR+,REUSABLE,1000ML,ANEROID,THUMBWHEEL,EA
10841522127762UNIFUSOR+,REUSABLE,500ML,ANEROID,THUMBWHEEL,EA
10841522120053UNIFUSOR+,REUSABLE,1000mL,CUFF ONLY,EA
10841522119965UNIFUSOR+,REUSABLE,500mL,CUFF ONLY,EA
10841522128035UNIFUSOR II,1000ML,PISTON,THUMBWHEEL,EA
10841522127915UNIFUSOR II,500ML,ANEROID,THUMBWHEEL,EA
10841522127908UNIFUSOR+,REUSABLE,3000ML,PISTON,STOPCOCK,EA
10841522127861UNIFUSOR+,REUSABLE,3000ML,PISTON,THUMBWHEEL,EA

Trademark Results [Unifuser]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIFUSER
UNIFUSER
74218494 1835193 Dead/Cancelled
UNIFUSER LIMITED
1991-11-04

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