AccessGUDID - DEVICE: Emit II Plus Oxycodone Positive Control 100 (00630414027999)

GUDID

Device Identifier (DI) Information

Brand Name: Emit II Plus Oxycodone Positive Control 100
Version or Model: 10720810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9T619UL
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414027999
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Emit II Plus Oxycodone Positive Control 100

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):	No
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?
55737	Oxycodone IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of oxycodone in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug specific control materials

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9f475d7-017f-4277-af3d-b5234c826f33
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: June 09, 2018