FDA.reportPublic FDA data

Kova Plastics

Primary DI
00850033297003
Brand
Kova Plastics
Company
Alltrista Plastics LLC
Model
KOVAPETTER
Catalog number
87135 / 87135E
Device description
Box containing 500 Kova petters (plastic pipettes 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
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033297003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033297003008500332970038500332970030850033297003

GMDN Terms#

Term, Definition table
TermDefinition
User-induced pipetteA device designed for the manual withdrawal, transfer, and injection of small volumes of fluid materials. It is made of glass or plastic and is designed as a long thin tube, typically with graduations along its length. The user will typically attach a mouthpiece and create a partial vacuum within the pipette by gently sucking the air from inside the tube inducing the liquid to enter the pipette, or achieve the same action with a squeezable bulb. Closing the mouthpiece or the user end of the pipette will hold the liquid therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb.

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

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