FDA.reportPublic FDA data

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb

Primary DI
00630414108766
Brand
MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Company
Siemens Healthcare Diagnostics Inc.
Model
10314213
Catalog number
473823
Device description
RAPIDLyte Multicap blood collection capillary tubes (100 tubes) approx. volume 60µL. Each tube contains 130-200 I.U./mL Na+/Li+/Ca++ heparin, titrated with KCl. For capillary blood collection for the analysis of pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414108766PrimaryGS10
00630414009414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414108766006304141087666304141087660630414108766
00630414009414006304140094146304140094140630414009414

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, electrolyte-balanced heparinA non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature4 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
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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