Norbuprenorphine DAU Calibrator, Intermediate Cali 0277

GUDID B07602770

5mL/bottle. Concentration: 20 ng/mL of Norbuprenorphine.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, calibrator Buprenorphine IVD, calibrator
Primary Device IDB07602770
NIH Device Record Key8970e7c9-af96-420f-afd6-26fde4d0f6a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorbuprenorphine DAU Calibrator, Intermediate Cali
Version Model Number0277
Catalog Number0277
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
HIBCCB07602770 [Primary]

FDA Product Code

DLJCalibrators, Drug Specific

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

On-Brand Devices [Norbuprenorphine DAU Calibrator, Intermediate Cali]

B076027805mL/bottle. Concentration: 40 ng/mL of Norbuprenorphine.
B076027705mL/bottle. Concentration: 20 ng/mL of Norbuprenorphine.

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