FDA.reportPublic FDA data

Transpac™

Primary DI
00840619040871
Brand
Transpac™
Company
ICU MEDICAL, INC.
Model
460730411
Catalog number
460730411
Device description
Cardiac Catheterization Basic Kit With Transpac™ IT and 3-Station, Right, ON, High Pressure Manifold
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932141000CARDIAC CATHETERIZATION KITAbbott Laboratories1994-09-22DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619040878PackageGS110In Commercial Distribution
00840619040871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904087810840619040878
00840619040871008406190408718406190408710840619040871

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
Kit
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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