AccessGUDID - DEVICE: QuikCoag Calcium Choride 0.02M (00627944000103)

GUDID

Device Identifier (DI) Information

Brand Name: QuikCoag Calcium Choride 0.02M
Version or Model: 10 mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biomedica Diagnostics Inc

Primary DI Number: 00627944000103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200152713 *Terms of Use

Device Description: No description.

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?
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
GFO	Activated Partial Thromboplastin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022021	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: 4a020f2c-2843-437f-9e8f-188701c1f7c9
Public Version Date: February 24, 2020
Public Version Number: 3
DI Record Publish Date: September 22, 2016