AccessGUDID - DEVICE: Buprenorphine 5 Qualitative Calibrator Set (00850624008070)

GUDID

Device Identifier (DI) Information

Brand Name: Buprenorphine 5 Qualitative Calibrator Set
Version or Model: 08356661190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08356661190
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: 00850624008070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: BUP 5 Cutoff Calibrator 5 ng/mL (1 x 5 mL).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42691	Buprenorphine IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	Calibrators, Drug Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1915dad-3a5a-48a4-902d-990e92d201cf
Public Version Date: October 15, 2018
Public Version Number: 4
DI Record Publish Date: April 20, 2018