FDA.reportPublic FDA data

Slope Gas

Primary DI
00630414112978
Brand
Slope Gas
Company
Siemens Healthcare Diagnostics Inc.
Model
10311038
Catalog number
477438000
Device description
Slope Gas for in vitro use on Siemens Healthcare Diagnostics Blood Gas analyzers and systems
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
BXXCALIBRATOR, PRESSURE, GAS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXXCalibrator, Pressure, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414112978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414112978006304141129786304141129780630414112978

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

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Primary DI, Brand, Company table
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