AccessGUDID - DEVICE: vWF Ag (00630414640433)

GUDID

Device Identifier (DI) Information

Brand Name: vWF Ag
Version or Model: 10873845
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873845
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414640433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma

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?
62196	Coagulation factor VIII-associated antigen IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen using a nephelometry/turbidimetry method. It is typically used in the diagnosis of congenital or acquired von Willebrand's disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGP	TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220728	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b41f5f0-fe7a-49d9-be41-3829db9e38f5
Public Version Date: April 08, 2024
Public Version Number: 1
DI Record Publish Date: March 29, 2024