FDA.report

Minivette® POCT 50µl LH, US

Primary DI
04038917320030
Brand
Minivette® POCT 50µl LH, US
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
17.2112.150
Catalog number
17.2112.150
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
04038917320023PrimaryGS10
04038917320030Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917320023040389173200234038917320023
04038917320030040389173200304038917320030

GMDN Terms

TermDefinition
Capillary blood collection tube IVD, lithium heparinA non-sterile glass or plastic collection tube containing the anticoagulant lithium heparin, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. 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
200
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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