AccessGUDID - DEVICE: Coagulation Factor XI Deficient Plasma (00842768009976)

GUDID

Device Identifier (DI) Information

Brand Name: Coagulation Factor XI Deficient Plasma
Version or Model: 10446316
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OSDF13
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768009976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods

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?
56042	Coagulation factor XI 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 quantitative measurement of coagulation factor XI in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJT	PLASMA, COAGULATION FACTOR DEFICIENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924396	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: a8f9e1fc-c200-41af-a566-72cd4c5f0c42
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016