FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619005955
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
011-CS-10
Catalog number
011-CS-10
Device description
Clave™ Connector IV Bag Access Device
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
K082836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082836000ICU MEDICAL UNIVERSAL SINGLE-USE SPIKESIcu Medical, Inc.2009-02-25FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619005952PackageGS150In Commercial Distribution
00840619005955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061900595210840619005952
00840619005955008406190059558406190059550840619005955

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted bag access spikeA small, noninvasive, tubular connector with a Luer connection (either lock or slip) at one end, and a hollow spike (either blunt or sharp) at the other end, intended to connect an intravenous (IV) fluid or blood bag to a fluid line or syringe for administration to a patient; it may in addition be used to draw medication from a vial, however it is not a vial/bottle adaptor. It may include an additional administration port (i.e., Y-site device), a built-in air filter, retention clamp, or valve(s); it does not however include tubing (i.e., not a tubing set). 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
10887709206905BivonaFU26JN40NSC136N2026-10-20
10887709206912BivonaFT26JN35NSE138N2026-10-20
10887709206936BivonaFT26JN60NSF126N2026-10-20
10887709206950BivonaFU26JN30NSE134N2026-10-20
10887709206967BivonaFU26JN35NSE135N2026-10-20
10887709206974BivonaFU26JN30NSF137N2026-10-20
10887709206981BivonaFT26JN40NSE142N2026-10-20
10887709206998BivonaFT26JN35NSE143N2026-10-20
10887709207001BivonaSU26JN50NSB144N2026-10-20
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16

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
00887709126794ICU MedicalICU MEDICAL, INC.FMG2023-07-10
00887709126800ICU MedicalICU MEDICAL, INC.FMG2023-06-21
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
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
04046955665075Extension SetB. BRAUN MEDICAL INC.FMG2021-02-08
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
04046955270347IV Administration SetB. BRAUN MEDICAL INC.FMG2019-02-22
10653160323679CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFMG2019-01-05
00690103199093FloTrac IQ, VAMP OptimaEdwards Lifesciences LLCFMG2018-11-20
00690103199161FloTrac IQ, VAMP OptimaEdwards Lifesciences LLCFMG2018-11-20
00690103199178FloTrac IQ, VAMP Optima, TruWaveEdwards Lifesciences LLCFMG2018-11-20