AccessGUDID - DEVICE: Atellica CH MetMtb (00630414595856)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH MetMtb
Version or Model: 11097527
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11097527
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414595856
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Atellica CH Methadone Metabolite (EDDP) (MetMtb)

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?
59050	2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJR	Enzyme immunoassay, methadone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023617	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: e1d85ed7-aba5-4ada-9a22-d06aa6cdfff2
Public Version Date: August 04, 2022
Public Version Number: 6
DI Record Publish Date: December 22, 2017