FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709087484
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH3673
Catalog number
CH3673
Device description
"86"" (218 cm) Appx 10.5 ml, 10 Drop Admin Set w/Integrated ChemoClave™ Drip Chamber, ChemoClave™, Sp"
Published
2021-07-27
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
ONBClosed antineoplastic and hazardous drug reconstitution and transfer system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173477000ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc.2018-08-31ONB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709087481PackageGS150In Commercial Distribution
00887709087484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770908748110887709087481
00887709087484008877090874848877090874840887709087484

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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18859299133857ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
00382905156298BD PhaSeal OptimaBD Switzerland SàrlONB2026-01-09
00382905156281BD PhaSeal OptimaBD Switzerland SàrlONB2025-12-19
18859299119950ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124114ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124121ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124138ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124145ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124152ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130696ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130702ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130719ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
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27290115921711OnGuard®2 20mm Vial Adaptor II and 13mm convertorSIMPLIVIA HEALTHCARE LTDONB2024-09-15
27290115921759OnGuard2 20mm Vial Adaptor, 10 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921872OnGuard2 20mm Vial Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921889OnGuard2 Syringe Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921896OnGuard2 Syringe Adaptor Lock II, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921865OnGuard2 Bag Adaptor SP IISIMPLIVIA HEALTHCARE LTDONB2024-05-06
27290115921827OnGaurd2 CSTD Catheter Adaptor SIMPLIVIA HEALTHCARE LTDONB2023-09-12
10885403470127MaxZeroBD Switzerland SàrlONB2023-07-27
00382905153013BD PhaSealBECTON DICKINSON PEN LIMITEDONB2023-07-27
00840619023720ICU MedicalICU MEDICAL, INC.ONB2023-06-02
00382905150708BD PhaSeal OptimaBD Switzerland SàrlONB2023-05-10
00382905153020BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905154065BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905150784BD PhaSeal OptimaBD Switzerland SàrlONB2023-04-26