FDA.report

Microvette® CB 200 NC

Primary DI
04038917201360
Brand
Microvette® CB 200 NC
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
18.1325.100
Catalog number
18.1325.100
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GHCTube, Sedimentation Rate
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications

CodeDeviceSpecialtyClass
GHCTube, Sedimentation RateHematology1
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917127653PrimaryGS10
04038917201360Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917127653040389171276534038917127653
04038917201360040389172013604038917201360

GMDN Terms

TermDefinition
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVDAn open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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