AccessGUDID - DEVICE: Dade Hepzyme (00630414640396)

GUDID

Device Identifier (DI) Information

Brand Name: Dade Hepzyme
Version or Model: 10873841
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873841
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414640396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing

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?
56207	Coagulation inhibitory substance neutralization 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 neutralization of any coagulation inhibitory substances in a clinical specimen through the addition of phospholipids. This is performed prior to testing using an activated partial thromboplastin time (APTT) test.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JBR	TEST, HEPARIN NEUTRALIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925452	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: bf846f26-08bc-4225-83fa-0f570fc04b34
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024