FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge LITH

Primary DI
00842768035326
Brand
Dimension Vista® Flex® reagent cartridge LITH
Company
Siemens Healthcare Diagnostics Inc.
Model
10635870
Catalog number
K4150
Device description
Lithium Flex® reagent cartridge, 180 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDWAssay, porphyrin, spectrophotometry, lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112142000DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2011-11-04NDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768035326PrimaryGS10
00630414005935Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768035326008427680353268427680353260842768035326
00630414005935006304140059356304140059350630414005935

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414287935Atellica CH Lithium_2 (LITH_2)Siemens Healthcare Diagnostics Inc.NDW2020-11-27
00630414288178ADVIA Chemistry Lithium_2 (LITH_2) reagentsSiemens Healthcare Diagnostics Inc.NDW2020-11-27
07613336121382LithiumRoche Diagnostics GmbHNDW2020-03-05
00380740136277AlinityABBOTT LABORATORIESNDW2018-07-30
00630414006789Atellica CH LiSiemens Healthcare Diagnostics Inc.NDW2017-12-21
00385480167291NOVANOVA BIOMEDICAL CORPORATIONNDW2017-04-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
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