Norbuprenorphine DAU Control, Level 1/Level 2 Cont 0274

GUDID B07602740

5mL/bottle. Concentration: 7 ng/mL of Norbuprenorphine.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, control Buprenorphine IVD, control
Primary Device IDB07602740
NIH Device Record Keyad5cbbd1-5feb-4c1d-b589-50415428a4d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorbuprenorphine DAU Control, Level 1/Level 2 Cont
Version Model Number0274
Catalog Number0274
Company DUNS840839190
Company NameLIN-ZHI INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07602740 [Primary]

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-15
Device Publish Date2016-07-05

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