FDA.reportPublic FDA data

Medex

Primary DI
10351688508560
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX20896R1
Published
2016-10-19
Public version status
Update
Distribution status
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
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790314000
K942377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790314000FLUID ADMINISTRATION SETS, 15 MICRONMedex, Inc.1979-03-06FPB
K942377000TRANSTAR PRESSURE TRANSDUCERMedex, Inc.1994-08-16DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688508568PackageGS110In Commercial Distribution
10351688508560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850856850351688508568
1035168850856010351688508560

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

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
46975124930965 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.FPB2026-04-11
00849884006179VYGONVygon CorporationFPB2023-06-05
08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
00763000419899Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
00763000419905Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
00849884005035VYGONVygon CorporationFPB2021-01-22
00849884005042VYGONVygon CorporationFPB2021-01-22
00085412639338EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-10-21
00085412639444FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412653297EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412660387EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
10849884002604VYGONVygon CorporationFPB2020-04-01
00849884004328VYGONVygon CorporationFPB2020-01-27
00849884000337VYGONVygon CorporationFPB2019-12-16
00849884000504VYGONVygon CorporationFPB2019-11-14
00849884002775VYGONVygon CorporationFPB2019-11-01
00849884001662VYGONVygon CorporationFPB2019-10-31
00849884002027VYGONVygon CorporationFPB2019-10-31
00849884002065VYGONVygon CorporationFPB2019-10-31
00842472100372MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCFPB2018-04-10
00818788021571EpimedEPIMED INTERNATIONAL, INCFPB2017-10-24
08498840010310VYGONVygon CorporationFPB2017-07-28
08498840010327VYGONVygon CorporationFPB2017-07-28
08498840010686VYGONVygon CorporationFPB2017-07-28
08426314580816GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314583503GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314604031GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05