LZI Oxycodone 300 Level 2 Control 0628

GUDID B07606280

5mL/bottle Concentration: 375 ng/mL of Oxycodone

LIN-ZHI INTERNATIONAL, INC.

Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control
Primary Device IDB07606280
NIH Device Record Keyc4f4fb29-0900-490c-9d00-901bfdf75b4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLZI Oxycodone 300 Level 2 Control
Version Model Number0628
Catalog Number0628
Company DUNS840839190
Company NameLIN-ZHI INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07606280 [Primary]

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-27
Device Publish Date2021-08-19

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