AccessGUDID - DEVICE: HemosIL Chromogenic Factor IX (00195226001129)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Chromogenic Factor IX
Version or Model: 0020012900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0020012900
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 00195226001129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Chromogenic Factor IX

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?
56249	Coagulation factor IX IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a chromogenic method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas 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 [?]
K230852	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: 0628a009-da5f-42e2-8ed6-381e12a0a60a
Public Version Date: July 17, 2024
Public Version Number: 1
DI Record Publish Date: July 09, 2024