Medex

Primary DI
50351688508773
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX20838
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790314000FLUID ADMINISTRATION SETS, 15 MICRONMedex, Inc.1979-03-06FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688508773PackageGS110In Commercial Distribution
10351688508775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850877350351688508773
1035168850877510351688508775

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
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887709098602ICU Medical, Inc.DS19022026-05-28
10887709194431BivonaFU26EN35NGE188N2026-05-28
10887709194448BivonaFU26EN35NGE189N2026-05-28
10887709194455BivonaXT26ES70NSC190N2026-05-28
10887709194462BivonaSU26EN50NGF192N2026-05-28
10887709194486BivonaFT26EN35NGF193N2026-05-28
10887709194509BivonaFT26EN40NGF194N2026-05-28
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000419899Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
00763000419905Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
20763000419893Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
20763000419909Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
15060484490157moorFLPI-2 Clinical PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2018-12-13
00643169630635Bio-Probe™MEDTRONIC, INC.DPT2017-01-22
00643169630642Bio-Probe™MEDTRONIC, INC.DPT2017-01-21
10351688507990MedexICU MEDICAL, INC.DPT2016-12-30
10351688508669MedexICU MEDICAL, INC.DPT2016-12-30
10351688516916MedexICU MEDICAL, INC.DPT2016-12-30
50351688508667MedexICU MEDICAL, INC.DPT2016-12-30
50351688516914MedexICU MEDICAL, INC.DPT2016-12-30
10351688503060MedexICU MEDICAL, INC.DPT2016-12-29
10351688505187MedexICU MEDICAL, INC.DPT2016-12-29
10351688505743MedexICU MEDICAL, INC.DPT2016-12-29
50351688505741MedexICU MEDICAL, INC.DPT2016-12-29
10351688503008MedexICU MEDICAL, INC.DPT2016-12-13
50351688503006MedexICU MEDICAL, INC.DPT2016-12-13
10351688503619MedexICU MEDICAL, INC.DPT2016-12-07
10351688503671MedexICU MEDICAL, INC.DPT2016-12-07
10351688503718MedexICU MEDICAL, INC.DPT2016-12-07
10351688503794MedexICU MEDICAL, INC.DPT2016-12-07
50351688503792MedexICU MEDICAL, INC.DPT2016-12-07
15060484490119moorFLPI-2 Review PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
15060484490126moorFLPI2- Measurement PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
10351688508416MedexICU MEDICAL, INC.DPT2016-10-19
10351688508423MedexICU MEDICAL, INC.DPT2016-10-19
10351688508560MedexICU MEDICAL, INC.DPT2016-10-19
10351688508775MedexICU MEDICAL, INC.DPT2016-10-19
10351688508782MedexICU MEDICAL, INC.DPT2016-10-19