AccessGUDID - DEVICE: IDG/Sanzay (00850053916205)

GUDID

Device Identifier (DI) Information

Brand Name: IDG/Sanzay
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HC301
Company Name: IDG/SANZAY Corporation

Primary DI Number: 00850053916205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948875013 *Terms of Use

Device Description: Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and recalcification (plasma clotting) time, as well as in various coagulation factor assays

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):	Yes
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?
30593	Calcium chloride coagulation reagent IVD	A calcium chloride solution intended to be used alone or in combination with other IVDs in the performance of coagulation tests or other laboratory investigations of clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJS	Test, Time, Prothrombin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020840	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: 599ce6d5-2b8a-41d3-ba77-b5d079abbb85
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 2024