FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709001862
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
B1473
Device description
"21"" WITHDRAWL KIT"
Published
2017-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052865000HOSPIRA CATH LAB CONVENIENCE KITSIcu Medical, Inc.2005-12-22DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709001869PackageGS150In Commercial Distribution
00887709001862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770900186910887709001869
00887709001862008877090018628877090018620887709001862

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.

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
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
10887709199061BivonaFT26GN50NGF159N2026-07-22
10887709198095BivonaFT26GN40NGF059N2026-07-21
10887709198521BivonaST26GN65NSC093N2026-07-21
10887709198897BivonaHT26GS50NSC139N2026-07-21
10887709198903BivonaHU26GS50NSC140N2026-07-21
10887709198910BivonaFU26GN45NSF142N2026-07-21
10887709198927BivonaFT26GN60NSF137N2026-07-21
10887709198934BivonaFT26GN70NSC136N2026-07-21
10887709198965BivonaXT26GS60NGF149N2026-07-21
10887709198972BivonaFT26GN40NSF150N2026-07-21
10887709198996BivonaFU26GN40NSF151N2026-07-21
10887709199009BivonaFT26GN45NSF147N2026-07-21
10887709199016BivonaFU26GN50NSF146N2026-07-21
10887709199023BivonaFU26GN45NGF148N2026-07-21
10887709199030BivonaFU26GN30NGE153N2026-07-21
10887709199047BivonaFU26GN35NGE152N2026-07-21
10887709199054BivonaXU26GS45NGF154N2026-07-21
10887709198491BivonaSU26EN50NGF192S2026-07-20
10887709198507BivonaSU26GN40NGF092N2026-07-20
10887709198514BivonaFT26GN60NSC091N2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
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07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
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07290017268019SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268026SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
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