AccessGUDID - DEVICE: PFA-100® System (00842768024870)

GUDID

Device Identifier (DI) Information

Brand Name: PFA-100® System
Version or Model: 10444868
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B4170-00
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768024870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: To aid in the detection of platelet dysfunction in citrated human whole blood

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?
56699	Platelet aggregation analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOZ	SYSTEM, AUTOMATED PLATELET AGGREGATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060489	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c0fa666-2147-4759-8077-64372d25ab5a
Public Version Date: September 16, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016