FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709120027
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CL3528T
Catalog number
CL3528T
Device description
30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, 0.2 Micron Filter, ChemoLock™ w/Red Cap, Bag Hanger
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K131549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131549000CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc.2013-07-26ONB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709120027PackageGS150In Commercial Distribution
00887709120020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770912002710887709120027
00887709120020008877091200208877091200200887709120020

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
1885929912157113 mm Vial ConverterEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-10-20
18859299130733ToxiSeal Vial Adaptor with External Flip BalloonEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-09-04
18859299121533ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
18859299121540ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
18859299121557ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
00850031983038Zephyrus InnovationsVAULT PARAGON GROUP, INC.ONB2026-05-21
18859299131013ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
18859299131051ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
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
27290115921858OnGuard2 Female Luer Lock AdaptorSIMPLIVIA HEALTHCARE LTDONB2025-08-17
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