Criticare Gemini

GUDID B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer

CRITICARE TECHNOLOGIES, INC.

Multiple vital physiological parameter monitoring system, clinical
Primary Device IDB438506DNP3US0
NIH Device Record Keycda917f9-5112-491d-84ef-0a1270cb191e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCriticare Gemini
Version Model NumberVitalCare 506DNP3
Company DUNS080402199
Company NameCRITICARE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB438506DNP3US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-16
Device Publish Date2024-07-08

On-Brand Devices [Criticare Gemini]

B438506LNVP30Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
B438506LNP30Monitor with Nellcor SPO2, NIBP, HR, and Printer
B438506DNVP30Monitor with DOX SPO2, NIBP, HR, Printer and Temp
B438506DNP3US0Monitor with DOX SPO2, NIBP, HR, and Printer

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