FDA.reportPublic FDA data

Gas Pressure Regulator

Primary DI
00630414467818
Brand
Gas Pressure Regulator
Company
Siemens Healthcare Diagnostics Inc.
Model
10310422
Catalog number
127191
Device description
Two stage gas Pressure Regulator for Siemens Healthcare Diagnostics Blood Gas 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
00630414467818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414467818006304144678186304144678180630414467818

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.

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
Serial number
true

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