AccessGUDID - DEVICE: ADVIA® 560 Lyse (00630414601878)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® 560 Lyse
Version or Model: 11170846
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D3015
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414601878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA® 560 Lyse

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?
61165	Blood cell lysis reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111534	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 15 and 25 Degrees Celsius
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2650b777-d5d2-43dc-8eec-82d985025c6e
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016