Medex

Primary DI
10351688504999
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX8133
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBTArterial blood sampling kit
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070340000
K820355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070340000SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.2007-03-15CBT
K820355000DISPOSABLE DIAPHRAGM DOMESMedex, Inc.1982-03-04DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688504997PackageGS110Not in Commercial Distribution
10351688504999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850499750351688504997
1035168850499910351688504999

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. 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

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