FDA.reportPublic FDA data

Kova Plastics

Primary DI
00850033297188
Brand
Kova Plastics
Company
Alltrista Plastics LLC
Model
88100
Catalog number
88100
Device description
Kova POC Urinalysis System Pac (Urinalysis package containing 100 plastic tubes, 100 plastic tube caps, 100 plastic pipettes, and 10 10-chambered plastic microscope slides with gridlines)
Published
2021-07-29
Public version status
Update
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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033297188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033297188008500332971888500332971880850033297188

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube IVD, non-sterileA non-sterile plastic tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(864) 879-8100csr@alltrista.com

Regulatory Flags#

DUNS number
197201572
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033297201Kova Plastics87145E87145E2022-05-12
00850033297218Kova Plastics87163E87163E2022-05-12
00850033297232Kova Plastics87158E87158E2022-05-12
00850033297003Kova PlasticsKOVAPETTER87135 / 87135E2021-07-29
00850033297010Kova PlasticsKOVACAP87139 / 87139E2021-07-29
00850033297027Kova PlasticsKOVASUPERTUBE87137 / 87137E2021-07-29
00850033297034Kova PlasticsKOVATUBE87138 / 87138E2021-07-29
00850033297041Kova PlasticsKOVASLIDE10w/GRID87144 / 87144E / 87144F2021-07-29
00850033297058Kova PlasticsKOVASLIDE1087146 / 87146E2021-07-29
00850033297065Kova PlasticsKOVASLIDEIIw/GRID87100 / 87100E2021-07-29
00850033297072Kova PlasticsKOVASLIDEII87118 / 87118E2021-07-29
00850033297089Kova Plastics8716287162 / 87162E2021-07-29
00850033297096Kova PlasticsKOVASLIDE1087157 / 87157E2021-07-29
00850033297102Kova Plastics8715387153 / 87153E2021-07-29
00850033297119Kova Plastics8714187141 / 87141E2021-07-29
00850033297126Kova Plastics8715487154 / 87154E2021-07-29
00850033297133Kova Plastics8715687156 / 87156E2021-07-29
00850033297195Kova Plastics8715587155 / 87155E2021-07-29
00850033297171Kova PlasticsKOVATUBESWKOVATUBESW2021-07-29
00850033297157Kova Plastics87136871362021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380008761CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380008785CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380036467CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380073714CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380084451CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380169004CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
00810111410861LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDNNK2026-08-07
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17