FDA.reportPublic FDA data

CO2 Adult Nasal Line

Primary DI
EMIP54000421
Brand
CO2 Adult Nasal Line
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
CO2 Adult Nasal Line
Catalog number
5400042
Published
2019-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142032000MRI PATIENT MONITORING SYSTEM TESLA M3Mipm Mammendorfer Institut Fur Physik Und Medizin2015-05-07MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMIP54000421PrimaryHIBCC0
EMIP54000420Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49814592090info@mipm.com

Regulatory Flags#

DUNS number
324416379
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04255629200973NIBP Pressure cuff 14 - 21,5 cmChild 14 - 21,5 cm51000392026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmSmall Adult 20,5 - 28,5 cm51000402026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmAdult 27 - 35 cm51000412026-06-24
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EMIP51000400NIBP Pressure cuff 20,5 - 28,5 cmSmall Adult 20,5 - 28,5 cm51000402019-11-11
EMIP51000410NIBP Pressure cuff 27 - 35 cmAdult 27 - 35 cm51000412019-11-11
EMIP51000420NIBP Pressure cuff 34 - 44 cmLarge Adult 34 - 44 cm51000422019-11-11
EMIP54000171Gas Sample Line SetGas Sample Line Set54000172019-11-11
EMIP51000430NIBP Pressure cuff 42 - 52 cmThigh 42 - 52 cm51000432019-11-11
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Primary DI, Brand, Company table
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