AccessGUDID - DEVICE: RTCII 2nd gen. (10694644500285)

GUDID

Device Identifier (DI) Information

Brand Name: RTCII 2nd gen.
Version or Model: 10-12BOX3A-030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-12BOX3A-030
Company Name: AMERICAN BIO MEDICA CORPORATION

Primary DI Number: 10694644500285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 966665036 *Terms of Use

Device Description: RTCII MINICUP 12 DRUG WITH SVT

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):	Yes
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?
55455	Multiple therapeutic drugs/drugs of abuse 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 multiple therapeutic drugs and drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJR	Enzyme Immunoassay, Methadone
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs
LAF	Gas Chromatography, Methamphetamine
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DIS	Enzyme Immunoassay, Barbiturate
DJG	Enzyme Immunoassay, Opiates
JXM	Enzyme Immunoassay, Benzodiazepine
LCM	Enzyme Immunoassay, Phencyclidine
LDJ	Enzyme Immunoassay, Cannabinoids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170222	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 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cc671fe-ea8b-4c26-bd90-514c0f775640
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 06, 2017