FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619024055
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH3028
Device description
"14"" Bifuse Add-On Set w/Bag Spike, Spiros®, Vented Cap"
Published
2019-07-08
Public version status
New
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081361000CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXXIcu Medical, Inc.2008-08-28FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619024052PackageGS150In Commercial Distribution
00840619024055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061902405210840619024052
00840619024055008406190240558406190240550840619024055

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.

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
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

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07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
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