FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709043920
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
42398-01
Catalog number
423980401
Device description
ANGIOGRAPHIC GUIDEWIRE .035 IN. DIAMETER X 150 CM USABLE LENGTH 15MM DISTAL 'J' TIP
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
10887709043920PackageGS125In Commercial Distribution
00887709043923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770904392010887709043920
00887709043923008877090439238877090439230887709043923

GMDN Terms#

Term, Definition table
TermDefinition
Centrally-inserted central venous catheterA flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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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
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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