FDA.reportPublic FDA data

Medex

Primary DI
10351688510655
Brand
Medex
Company
ICU MEDICAL, INC.
Model
M20770R1
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
FPASet, administration, intravascular
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2
FPASet, Administration, IntravascularGeneral Hospital2
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790314000
K820355000
K943897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790314000FLUID ADMINISTRATION SETS, 15 MICRONMedex, Inc.1979-03-06FPB
K820355000DISPOSABLE DIAPHRAGM DOMESMedex, Inc.1982-03-04DRS
K943897000NU-SITEMedex, Inc.1995-02-10FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688510653PackageGS110In Commercial Distribution
10351688510655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168851065350351688510653
1035168851065510351688510655

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
Primary DIBrandModelCatalogPublished
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27
10887709207292BivonaSA26JN75NSC152N2026-10-27
10887709207308BivonaSU26JN40NSB163S2026-10-27
10887709207315BivonaFU26JN45NSF173N2026-10-27
10887709207322BivonaXT26JS80NSC172N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
15034480300925Pall Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315752Pall Lipipor NLF1A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315769Pall Lipipor NLF2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315776Pall Lipipor NLF2NTA Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
00885403530695Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531715FloTrac JrBecton, Dickinson And CompanyDRS2026-09-04
00885403531722Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531814FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531821FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531913FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531920FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531937FloTracBecton, Dickinson And CompanyDRS2026-09-04
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
00885403531845FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403541974FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31