FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619078454
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH4006
Catalog number
CH4006
Device description
"30"" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros™"
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
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
10840619078451PackageGS125In Commercial Distribution
00840619078454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061907845110840619078451
00840619078454008406190784548406190784540840619078454

GMDN Terms#

Term, Definition table
TermDefinition
Compounding transfer setA collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. 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
10887709199375BivonaFT26GN30NGE185N2026-07-24
10887709199399BivonaFU26GN35NSF191N2026-07-24
10887709199405BivonaSU26GN60NSC193N2026-07-24
10887709199412BivonaFT26GN40NSF192N2026-07-24
10887709199429BivonaFT26GN35NSF194N2026-07-24
10887709199443BivonaFU26GN50NGF200N2026-07-24
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23

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