FDA.report

Microvette® CB 300 Z

Primary DI
04038917184465
Brand
Microvette® CB 300 Z
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
16.440.100
Catalog number
16.440.100
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
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications

CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917268325PrimaryGS10
04038917184465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917268325040389172683254038917268325
04038917184465040389171844654038917184465

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
388000270
Device count
100
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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