ICU Medical

Primary DI
00840619040901
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46094-37
Catalog number
46094-37
Device description
Monitoring Kit With 03ML Flush Device For NYU MED CTR
Published
2021-08-29
Public version status
Update
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
DRSTransducer, blood-pressure, extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052828000DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)Hospira, Inc.2006-02-17DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619040908PackageGS120In Commercial Distribution
00840619040901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904090810840619040908
00840619040901008406190409018406190409010840619040901

GMDN Terms#

Term, Definition table
TermDefinition
In-line arterial blood sampling setA collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
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
10887709201016BivonaFU26HN30NSE091N2026-08-19
10887709201450BivonaFT26HN40NSF114N2026-08-19
10887709201504BivonaFT26HN30NSE122N2026-08-19
10887709201528BivonaFU26HN45NSA120N2026-08-19
10887709201535BivonaFU26HN40NSF117N2026-08-19
10887709201542BivonaFT26HN35NGF123N2026-08-19
10887709201559BivonaFT26HN50NSA119N2026-08-19
10887709201566BivonaFT26HN40NGF124N2026-08-19
10887709201573BivonaHT26HS80NSB126N2026-08-19
10887709201603BivonaFP26HN25NGE127N2026-08-19
10887709201610BivonaSU26HN35TGE116N2026-08-19
10887709201351BivonaAA26HS60NGC079N2026-08-18
10887709201368BivonaFT26HN60NGF108N2026-08-18
10887709201375BivonaFT26HN40NGF109N2026-08-18
10887709201399BivonaFU26HN60NGA111N2026-08-18
10887709201405BivonaFT26HN35NSA113N2026-08-18
10887709201412BivonaFT26HN40NGA090N2026-08-18
10887709201429BivonaFT26GN45NSF190N2026-08-18
10887709201436BivonaFU26HN30NGA098N2026-08-18
10887709201443BivonaFU26HN25NSA099N2026-08-18

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Primary DI, Brand, Company table
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00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
00887709089785ICU MedicalICU MEDICAL, INC.DRS2021-08-29
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