FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619023379
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
20129-01
Catalog number
20129-01
Device description
Sterile Cap (5 Pack)
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
K964435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964435000PRIMARY IV SETIcu Medical, Inc.1997-04-02FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619023376PackageGS150In Commercial Distribution
00840619023379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061902337610840619023376
00840619023379008406190233798406190233790840619023379

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. 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
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

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
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