AccessGUDID - DEVICE: Atellica™ CH D-HDL (00630414596204)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ CH D-HDL
Version or Model: 11097630
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11097630
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414596204
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Direct HDL Cholesterol (D-HDL) Atellica™ CH - RGT 1792T

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?
53391	High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBS	LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

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
Special Storage Condition, Specify: 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: 27b71282-72ab-4cca-a0f1-bf60f2445d3c
Public Version Date: October 21, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2020