FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619058876
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH3353
Catalog number
CH3353
Device description
"60"" Smallbore Ext Set w/MicroClave™ Clear, Spiros™, Clamp"
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070532000SPIROSIcu Medical, Inc.2007-03-20FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619058873PackageGS150In Commercial Distribution
00840619058876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061905887310840619058873
00840619058876008406190588768406190588760840619058876

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. 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
10887709206011BivonaXU26JS35NGF064N2026-10-08
10887709206028BivonaFT26JN45NGF062N2026-10-08
10887709206035BivonaFP26JN35NGE061N2026-10-08
10887709206042BivonaFU26JN35NGA059N2026-10-08
10887709206059BivonaXU26JS35NGA058N2026-10-08
10887709206073BivonaFT26JN55NSF056N2026-10-08
10887709206080BivonaST26JN50NGG057N2026-10-08
10887709205687BivonaFT26JN35NGF033N2026-10-07
10887709205694BivonaFT26JN35NGE208N2026-10-07
10887709205847BivonaSU26JN65NSC047N2026-10-07
10887709205854BivonaSU26JN65NSC048N2026-10-07
10887709205861BivonaXT26JS80NSC050N2026-10-07
10887709205878BivonaXT26JS80NSC051N2026-10-07
10887709205885BivonaFU26JN35NGE052N2026-10-07
10887709205892BivonaFU26JN30NGE053N2026-10-07
10887709205908BivonaFU26JN55NGF046N2026-10-07
10887709205915BivonaFT26JN45NSC045N2026-10-07
10887709205922BivonaSU26JS65NSC049N2026-10-07
10887709205939BivonaFT26JN35NGE043N2026-10-07
10887709205946BivonaFT26JN40NGE044N2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23