AccessGUDID - DEVICE: Synermed® (05060500091194)

GUDID

Device Identifier (DI) Information

Brand Name: Synermed®
Version or Model: IR170-911
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IR170-911
Company Name: INFRARED LABORATORY SYSTEMS LLC

Primary DI Number: 05060500091194
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014210494 *Terms of Use

Device Description: Magnesium Reagent 4 X 20 mL

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
52883	Magnesium (Mg2+) 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 of magnesium (Mg2+) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JGJ	Photometric Method, Magnesium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K902919	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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c002e5a6-2675-49d3-904a-4fcdff797794
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016