AccessGUDID - DEVICE: Dade® PFA Collagen/EPI Test Cartridge (00842768003660)

GUDID

Device Identifier (DI) Information

Brand Name: Dade® PFA Collagen/EPI Test Cartridge
Version or Model: 10445697
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B4170-20A
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768003660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
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:	Yes
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?
56092	Platelet aggregation study IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.	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
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23b19109-21df-4ac9-9add-7d619350bf2e
Public Version Date: February 26, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016