FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709067387
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46111-61
Catalog number
46111-61
Device description
3-Way Stopcock w/2 Needleless Valves and 03 ml Syringe
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K061573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061573000TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITHospira, Inc.2006-09-19DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709067384PackageGS125In Commercial Distribution
00887709067387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770906738410887709067384
00887709067387008877090673878877090673870887709067387

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line stopcockA sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206622BivonaZT26JN45NSF109N2026-10-26
10887709206639BivonaZT26JN40NSE108N2026-10-26
10887709206790BivonaZU26JN60NSC128N2026-10-26
10887709206806BivonaST22LN60NSZ210N2026-10-26
10887709207025BivonaSA26JN95ZSC110N2026-10-26
10887709207384BivonaFT26JN35NGA179N2026-10-26
10887709207391BivonaFU26JN35NGA180N2026-10-26
10887709207438BivonaFT26JN50NSA183N2026-10-26
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00885403531845FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403541974FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403531654Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
00887709089785ICU MedicalICU MEDICAL, INC.DRS2021-08-29
06945764400403AntmedShenZhen Antmed Co., LtdDRS2017-08-24
06945764404135AntmedShenZhen Antmed Co., LtdDRS2017-08-24
H6713000060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23