FDA.reportPublic FDA data

Gas Sample Line Set

Primary DI
04255629201017
Brand
Gas Sample Line Set
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
Gas Sample Line Set
Catalog number
5400017
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
EMIP54000171PreviousHIBCC0
04255629201017PrimaryGS10
04255629201024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255629201017042556292010174255629201017
04255629201024042556292010244255629201024

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthetic agent gas monitor, multipleA mains electricity (AC-powered) instrument designed for the continuous and simultaneous sampling, measuring, and display of concentrations of more than one gaseous anaesthetic agent (e.g., halothane, desflurane, Ethrane, isoflurane) in a breathing system (e.g., at an anaesthetic unit/workstation outlet or from a bedside breathing/sampling system), to ensure that appropriate agent levels are administered to a patient. It may also measure inspired and/or expired oxygen (O2) and/or carbon dioxide (CO2). Methods to determine gas concentrations include infrared (IR) spectrometry, ultraviolet (UV) absorption, interferometry, and ultrasound.

Contacts#

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

Regulatory Flags#

DUNS number
324416379
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04255629201000NIBP Pressure cuff 34 - 44 cmLarge Adult 34 - 44 cm51000422026-06-24
EMIP51000380NIBP Pressure cuff 9 - 15 cmInfant 9 - 15 cm51000382019-11-11
EMIP51000390NIBP Pressure cuff 14 - 21,5 cmChild 14 - 21,5 cm51000392019-11-11
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
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EMIP51000430NIBP Pressure cuff 42 - 52 cmThigh 42 - 52 cm51000432019-11-11
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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