AccessGUDID - DEVICE: Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator (B076S02980)

GUDID

Device Identifier (DI) Information

Brand Name: Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator
Version or Model: S0298
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S0298
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B076S02980
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: 5 mL/bottle. Concentration: 0 ng/mL of 6-Acetylmorphine.

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?
55465	6-Acetyl morphine 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 6-acetyl morphine 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 [?]
K141205	000

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: 9f4968ae-97ba-4d59-ba49-477a732c289e
Public Version Date: August 23, 2018
Public Version Number: 4
DI Record Publish Date: July 05, 2016