FDA.reportPublic FDA data

Kova Plastics

Primary DI
00850033297034
Brand
Kova Plastics
Company
Alltrista Plastics LLC
Model
KOVATUBE
Catalog number
87138 / 87138E
Device description
Box of 500 Kova Econotubes (plastic graduated sample tubes) for use in 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
00850033297034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033297034008500332970348500332970340850033297034

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
Handling 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
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
00850033297171Kova PlasticsKOVATUBESWKOVATUBESW2021-07-29
00850033297157Kova Plastics87136871362021-07-29

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