GUDID 00840682124683

ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable
Primary Device ID00840682124683
NIH Device Record Keyc3b800ac-aff8-4a55-b8cf-abd09465aac6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2089791-003
Company DUNS006580799
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx

Device Dimensions

Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter
Length3.6 Meter

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682124683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQblood pressure cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-04-18
Device Publish Date2020-03-25

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00840682124669 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 2.4M
00840682124683 - NA2025-04-18ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M
00840682124683 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M
00195278421449 - CAM2025-04-15 CAM 14 - MDR
00195278421456 - CAM2025-04-15 CAM HD - MDR
00195278364661 - CardioSoft2025-04-02 CARDIOSOFT V7.0 SP7.2
00195278403643 - CASE2025-04-02 CASE V7.0
00195278617644 - CASE2025-04-02 CASE V7 GENERIC ATO

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