AccessGUDID - DEVICE: Oratect Oral Fluid Collection Tube (00816565020847)

GUDID

Device Identifier (DI) Information

Brand Name: Oratect Oral Fluid Collection Tube
Version or Model: CM-190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CM-190
Company Name: AMEDITECH INC.

Primary DI Number: 00816565020847
Issuing Agency: GS1
Commercial Distribution End Date: October 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 010551716 *Terms of Use

Device Description: Oral Fluid Specimen Collection Tube

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
38868	Drug-testing specimen collection kit IVD	A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCM	Enzyme Immunoassay, Phencyclidine
DJG	Enzyme Immunoassay, Opiates
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids
DJC	Thin Layer Chromatography, Methamphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103227	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
Special Storage Condition, Specify: Store collected specimen between 2 to 8 Degrees Celsius.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 201ec915-6e8e-40d9-abaf-d391a276c33a
Public Version Date: November 14, 2023
Public Version Number: 6
DI Record Publish Date: March 31, 2017