AccessGUDID - DEVICE: Atellica CH DLDL (00630414596181)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH DLDL
Version or Model: 11097632
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11097632
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414596181
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T

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?
53395	Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRR	SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982529	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: 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: 2471232c-e785-4131-a8dd-17bfd362e43c
Public Version Date: March 07, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2020