AccessGUDID - DEVICE: Syva® Emit® II Plus Ethyl Alcohol Assay (00842768002038)

GUDID

Device Identifier (DI) Information

Brand Name: Syva® Emit® II Plus Ethyl Alcohol Assay
Version or Model: 10445453
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9K409UL
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768002038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Syva® Emit® II Plus Ethyl Alcohol Assay - 1 L Kit

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?
55608	Ethanol (ETOH) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ethyl alcohol (ETOH) in a clinical specimen, using a spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DML	NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993980	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: 93ae5c5d-4524-4be2-aa6d-6973bf81d506
Public Version Date: April 26, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016