FDA.reportPublic FDA data

NIBP Pressure cuff 42 - 52 cm

Primary DI
EMIP51000430
Brand
NIBP Pressure cuff 42 - 52 cm
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
Thigh 42 - 52 cm
Catalog number
5100043
Published
2019-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
EMIP51000430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
324416379
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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