Kova Plastics

Basic Information

• Brand Name: Kova Plastics
• Primary DI: 00850033297102
• Version / Model: 87153
• Catalog Number: 87153 / 87153E
• Company Name: Alltrista Plastics LLC
• Labeler DUNS: 197201572
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-29
• Public Version: 3
• Public Version Date: 2022-05-13
• Public Version Status: Update
• Public Device Record Key: 30c65957-2cf2-49a1-aeba-bcb809899058

Device Description

Kova System Super Pac 1000 + Caps (Urinalysis package containing 1000 plastic tubes, 1000 plastic caps, 1000 plastic pipettes, and 100 10-chambered plastic microscope slides without gridlines)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62229	Test tube/reservoir cap	A covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.	No	Active
43761	Centrifuge tube IVD	A 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.	No	Active
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	No	Active
43375	User-induced pipette	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033297102	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius