AccessGUDID - DEVICE: HemosIL Liquid Anti-Xa (00195226000016)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Liquid Anti-Xa
Version or Model: 0020302602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020302602
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 00195226000016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0020302622) 5 x 3 mL

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
56180	Coagulation factor Xa inhibitor IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen, using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLU	Anti-Factor Xa Activity Test System, Apixaban

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190032	000
K213464	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: a23cefc2-5ccd-478e-b5fc-4775f94a9c78
Public Version Date: November 24, 2022
Public Version Number: 5
DI Record Publish Date: March 15, 2021