FDA.reportPublic FDA data

Minivette® POCT 50µl K3E, US

Primary DI
04038917320085
Brand
Minivette® POCT 50µl K3E, US
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
17.2113.150
Catalog number
17.2113.150
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04038917320085PrimaryGS10
04038917320092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917320085040389173200854038917320085
04038917320092040389173200924038917320092

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, K2EDTAA non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917927048Sediplus® S 2000 NX90.109290.10922026-07-22
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PS95.1000.47695.1000.4762026-07-21
04038917124935ESR RACK N/BACK PANEL90.1060.06290.1060.0622026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CB95.1000.47795.1000.4772026-07-21
04038917581882Salivette®51.1534.10051.1534.1002026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04066916055837Screw cap, pastel-green65.716.04565.716.0452026-07-21
04066916055998Screw cap, pastel-orange65.716.04665.716.0462026-07-21
04066916056049Screw cap, pastel-violet65.716.04865.716.0482026-07-21
04066916056148Screw cap, pastel-yellow65.716.04265.716.0422026-07-21
04066916056407Screw cap, pastel-blue65.716.04165.716.0412026-07-21
04066916057831SafeSeal tube 0.5ml72.704.05072.704.0502026-07-21
04066916057879SafeSeal tube 0.5ml, brown72.704.05172.704.0512026-07-21
04066916058012SafeSeal tube 0.5ml, red72.704.05272.704.0522026-07-21
04066916058050SafeSeal tube 0.5ml, yellow72.704.05472.704.0542026-07-21
04066916058135SafeSeal tube 0.5ml, green72.704.05572.704.0552026-07-21
04066916058173SafeSeal tube 0.5ml, blue72.704.05672.704.0562026-07-21
04066916058210Micro tube 0.5ml SafeSeal72.704.45072.704.4502026-07-21
04066916058296SafeSeal tube 1.5ml72.706.05072.706.0502026-07-21
04066916058340SafeSeal tube 1.5ml, brown72.706.05172.706.0512026-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00857182006807UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
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10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
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