AccessGUDID - DEVICE: Vancomycin ONLINE TDM Vancomycin (04015630997961)

GUDID

Device Identifier (DI) Information

Brand Name: Vancomycin ONLINE TDM Vancomycin
Version or Model: 4642490190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4642490190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630997961
Issuing Agency: GS1
Commercial Distribution End Date: November 07, 2018
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?
61035	Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEH	RADIOIMMUNOASSAY, VANCOMYCIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060586	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: fbd9a5e0-eb21-4681-8e3c-542fbb21dd7b
Public Version Date: October 09, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016