FDA.reportPublic FDA data

IVX Station Stock Solution Transfer Set

Primary DI
10860007260404
Brand
IVX Station Stock Solution Transfer Set
Company
Omnicell, Inc.
Model
IVX Station Stock Solution Transfer Set
Device description
The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
Published
2023-06-06
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

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212530000IVX Fluid Transfer SetOmnicell, Inc.2022-04-24LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860007260404PackageGS15In Commercial Distribution
20860007260401PackageGS110In Commercial Distribution
00860007260407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000726040410860007260404
2086000726040120860007260401
00860007260407008600072604078600072604070860007260407

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080513111
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00860007260421IVX Station Reconstitution Transfer SetIVX Station Reconstitution Transfer Set2025-01-23
00860006285043IVX ManagerIVX Manager2024-05-10
00860006285036IVX CloudIVX Cloud2024-01-10
00860006285029IVX CloudIVX Cloud2021-06-25
00860007260407IVX Station Stock Solution Transfer SetIVX Station Stock Solution Transfer Set2023-06-06
00860006285012XT Anesthesia Workstation (AWS)XT-AWS2021-02-15
00860006285005IVX StationIVX Station2021-02-08

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Primary DI, Brand, Company table
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