FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709064508
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46111-39
Catalog number
46111-39
Device description
"15' (180"") Pressure Tubing Extension Set"
Published
2021-08-29
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
DQOCatheter, intravascular, diagnostic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709064505PackageGS150In Commercial Distribution
00887709064508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770906450510887709064505
00887709064508008877090645088877090645080887709064508

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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