AccessGUDID - DEVICE: HemosIL D-Dimer HS 500 Controls (Liquid) (08426950584933)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL D-Dimer HS 500 Controls (Liquid)
Version or Model: 00020013100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00020013100
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950584933
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL D-Dimer HS 500 Controls (Liquid)

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:	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?
47347	D-dimer IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	PLASMA, COAGULATION CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133582	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
Special Storage Condition, Specify: Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61b92614-4ca6-41eb-990e-277a68a22b8a
Public Version Date: July 13, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016