Cardinal Health 89210

GUDID 00855617006545

CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, 25mL

KOVA INTERNATIONAL, INC.

Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control
Primary Device ID00855617006545
NIH Device Record Key3ecb7cd7-2d3d-426d-9fbd-b722c397d791
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardinal Health
Version Model Number89210
Catalog Number89210
Company DUNS078780990
Company NameKOVA INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com
Phone714-902-1700
Emailcs@kovaintl.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]
GS100855617006545 [Primary]

FDA Product Code

JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)
JJWUrinalysis Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Cardinal Health]

00855617006538Sediment Centrifugation Tube 1000
00855617006521Straight Wall Urine Tube, 12mL
00850015517099CARDINAL HEALTH® UA CONTROL TUBE SET, 15mL
00855617006477CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, 120mL
00855617006460CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, 5mL
00855617006545CARDINAL HEALTH® UA CONTROL DROPPER BOTTLE SET, 25mL

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.