FDA.reportPublic FDA data

Microvette® 200 Z

Primary DI
04066916001865
Brand
Microvette® 200 Z
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
20.1290.200
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04066916001865PrimaryGS10
04066916001858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066916001865040669160018654066916001865
04066916001858040669160018584066916001858

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, clot activatorA non-sterile glass or plastic capillary blood transfer tube coated internally with a clot activator, and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Regulatory Flags#

DUNS number
388000270
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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04038917134170S-Monovette®04.1901.10004.1901.1002016-09-16
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04038917350334S-Monovette®02.1066.10002.1066.1002016-09-16
04038917361668S-Monovette®05.1081.10005.1081.1002016-09-16
04038917370196S-Monovette®04.1931.01304.1931.0132016-09-16
04038917382250S-Monovette®04.1915.10004.1915.1002018-01-03
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04038917317658RC 1200 S 15 Hitachi, 115V90.197.10190.197.1012022-11-30
04038917536783DC 1200, Decapper Eurolab,115V90.198.51890.198.5182022-11-30
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