FDA.reportPublic FDA data

Bicarbonate liquid

Primary DI
04015630919376
Brand
Bicarbonate liquid
Company
Roche Diagnostics GmbH
Model
3289885190
Catalog number
3289885190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHSENZYMATIC, CARBON-DIOXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032377000ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUIDRoche Diagnostics Corp.2003-08-21KHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630919376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630919376040156309193764015630919376

GMDN Terms#

Term, Definition table
TermDefinition
Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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