FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709097773
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
AC311
Catalog number
AC311
Device description
3 Gang 4-Way NanoClave? Stopcock w/NanoClave?, Baseplate, Rotating Luer
Published
2021-08-24
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
FMGStopcock, i.V. Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080077000CLAVE STOPCOCKIcu Medical, Inc.2008-02-13FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709097770PackageGS150In Commercial Distribution
00887709097773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770909777010887709097770
00887709097773008877090977738877090977730887709097773

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
10887709205281BivonaZT26IN40NGF212N2026-10-01
10887709205298BivonaZT26IN45NGF211N2026-10-01
10887709205304BivonaZT26IN45NGF210N2026-10-01
10887709205311BivonaSZ26IN60NGZ222N2026-10-01
10887709205328BivonaFT26IN35NGE217N2026-10-01
10887709205335BivonaHT26IS70NSC219N2026-10-01
10887709205342BivonaHT26IS80NSC218N2026-10-01
10887709205359BivonaSU26IN60NSC220N2026-10-01
10887709205366BivonaFT26IN40NGE221N2026-10-01
10887709205373BivonaFT26IN30NGF223N2026-10-01
10887709205380BivonaFU26JN50NGF001N2026-10-01
10887709205397BivonaHT26JS85NSC002N2026-10-01
10887709205410BivonaXA26JS60NGF004N2026-10-01
10887709205427BivonaFU26JN40NGE003N2026-10-01
10887709205014BivonaFT26IN70NSZ174N2026-09-30
10887709205021BivonaZU26IS45NGF176N2026-09-30
10887709205038BivonaZU26IS40NGF175N2026-09-30
10887709205045BivonaZT26IN35NSB180N2026-09-30
10887709205052BivonaFU26IN40NGZ015N2026-09-30
10887709205069BivonaZT26IN50NGC149N2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23700550400763Qitexio 4-Way StopcockMEDEXFMG2025-05-09
00382903949106Connecta, Luer-LokBD Switzerland SàrlFMG2023-09-21
00634624921092High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921108High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921160High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921191High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921184High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921245High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFMG2022-11-30
10193489896824Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMG2022-08-04
00840619006174ICU MedicalICU MEDICAL, INC.FMG2021-10-05
00840619006136ICU MedicalICU MEDICAL, INC.FMG2021-08-29
00840619005955ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006020ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006075ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006730ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023232ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023249ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619000028ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619000042ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001537ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001650ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001742ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001773ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00749756310734DeRoyalDEROYAL INDUSTRIES, INC.FMG2021-07-12
00634624911017Q2 High Flow StopcockQUEST MEDICAL INCFMG2021-05-12
20634624911028Q2 High Flow Stopcock, BNSQUEST MEDICAL INCFMG2021-05-12
10193489191684MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10193489191707MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10888439636703CARDINAL HEALTHCardinal Health 200, LLCFMG2019-12-17
10653160330936CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFMG2019-11-05