Medex

Primary DI
10351688517760
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MG300222R1
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820355000DISPOSABLE DIAPHRAGM DOMESMedex, Inc.1982-03-04DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688517768PackageGS110In Commercial Distribution
10351688517760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168851776850351688517768
1035168851776010351688517760

GMDN Terms#

Term, Definition table
TermDefinition
Pressure transducer dome, single-useA sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10887709204901BivonaFT26IN60NGF183N2026-09-25
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10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

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