AccessGUDID - DEVICE: ADVIA® 120/2120/2120i TESTpoint Retic High Control (00630414224442)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® 120/2120/2120i TESTpoint Retic High Control
Version or Model: 10312295
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T03-3691-54
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414224442
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA®120/2120/2120i TESTpoint™ Retic High Control

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?
30537	Reticulocyte count IVD, control	A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905524	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 freezing
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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: 272de8bc-58d0-48eb-bce5-c10a0d2a386c
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016