AccessGUDID - DEVICE: Atellica IM Dgtn (00630414598772)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Dgtn
Version or Model: 10995553
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10995553
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598772
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2024
Device Count: 5
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Digitoxin (Dgtn) Atellica IM - RGT 250T

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?
60978	Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digitoxin in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFM	ENZYME IMMUNOASSAY, DIGITOXIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970546	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
Special Storage Condition, Specify: Store upright, Protect from light
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: 4b1197eb-7f57-45ec-b0f3-73f4887308db
Public Version Date: July 17, 2024
Public Version Number: 6
DI Record Publish Date: February 06, 2018