FDA.reportPublic FDA data

Transpac

Primary DI
00840619033552
Brand
Transpac
Company
ICU MEDICAL, INC.
Model
42587-05
Device description
"Transpac® IV Monitoring Kit, 60"", Disposable Transducer, 3 ML Intraflo® Flush, Macrodrip (Pole Mount)"
Published
2017-12-18
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
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932188000SAFESET RESERVOIRAbbott Laboratories1993-10-25KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619033559PackageGS120In Commercial Distribution
00840619033552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061903355910840619033559
00840619033552008406190335528406190335520840619033552

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05
10887709195018BivonaXU26FS35NGA039N2026-06-05
10887709195025BivonaXU26FS55NGC029N2026-06-05
10887709195032BivonaFT26FN45NSF030N2026-06-05
10887709195049BivonaFU26FN60NSA032N2026-06-05
10887709195056BivonaFT26FN25NGE033N2026-06-05
10887709195063BivonaFT26FN30NGE034N2026-06-05
10887709195070BivonaHT26FS70NSC042N2026-06-05
10887709195087BivonaSU26FN35NGF041N2026-06-05
10887709195094BivonaFT26FN30NGF045N2026-06-05
10887709195100BivonaFT26FN25NGF044N2026-06-05
10887709195117BivonaFA26FN70NSC047N2026-06-05
10887709195124BivonaFU26FN70NTC048N2026-06-05
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506067342TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067359TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067366TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067373TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyKRA2026-05-30
00885403523819VAMPBecton, Dickinson And CompanyKRA2026-05-30
00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023955Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
00763000539351RebarMicro Therapeutics, Inc.KRA2022-02-27
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01