FDA.reportPublic FDA data

Kova Plastics

Primary DI
00850033297171
Brand
Kova Plastics
Company
Alltrista Plastics LLC
Model
KOVATUBESW
Catalog number
KOVATUBESW
Device description
Box containing 500 Kova Straight Wall Tubes (Plastic graduated sample tubes for urinalysis)
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
00850033297171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033297171008500332971718500332971710850033297171

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
00850033297188Kova Plastics88100881002021-07-29
00850033297195Kova Plastics8715587155 / 87155E2021-07-29
00850033297157Kova Plastics87136871362021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840216129801LabCorpAsp Global, LLCNNK2026-07-17
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03