AccessGUDID - DEVICE: ONLINE TDM Lidocaine (04015630996933)

GUDID

Device Identifier (DI) Information

Brand Name: ONLINE TDM Lidocaine
Version or Model: 3376222190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3376222190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630996933
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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?
55343	Lidocaine therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug lidocaine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLR	ENZYME IMMUNOASSAY, LIDOCAINE

FDA Premarket Submission

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

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: 586a8f57-815f-47f8-9974-76c615d61b16
Public Version Date: November 11, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016