FDA.reportPublic FDA data

Minivette® POCT 20µl

Primary DI
04038917251327
Brand
Minivette® POCT 20µl
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
17.2111.020
Catalog number
17.2111.020
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

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
04038917251310PrimaryGS10
04038917251327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917251310040389172513104038917251310
04038917251327040389172513274038917251327

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, no additiveA glass or plastic collection tube containing no additive, 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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917968560SAHARA-TSC 115V97.8710.60297.8710.6022023-11-24
04038917080873Push cap, neutral65.10965.1092022-11-30
04038917081306Tube 10ml, 95x16.8mm, K3E26.35826.3582022-11-30
04038917081344Tube 10ml, 95x16.8mm, LH26.36926.3692022-11-30
04038917082952Faeces tube 75x23.5mm80.62080.6202022-11-30
04038917082969Faeces tube 75x23.5mm80.62180.6212022-11-30
04038917083096Sample cup 3.5ml, PS73.64673.6462022-11-30
04038917083195Sample cup 2ml for ES300/60073.66373.6632022-11-30
04038917083232Sample cup for AXSYM73.66773.6672022-11-30
04038917083409Micro tube 1.5ml, PP72.68872.6882022-11-30
04038917083416Micro tube 2ml, PP72.68972.6892022-11-30
04038917083508Micro tube 0.5ml, PP72.69872.6982022-11-30
04038917083713Push cap, neutral65.72365.7232022-11-30
04038917083959Round cuvette, PP68.75268.7522022-11-30
0403891708484096 PCR Plate Biosphere® Plus72.98572.9852022-11-30
04038917085595Transfer pipette 3.5ml86.117386.11732023-01-12
04038917085618Transfer pipette 6ml86.117586.11752023-01-12
04038917085632Transfer pipette 1ml86.117986.11792023-01-12
04038917109710Tube 5ml, 75x12mm, PP, MF55.526.05355.526.0532022-11-30
04038917111713Tube 30ml, 107x25mm, PP62.543.03062.543.0302022-11-30

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