AccessGUDID - DEVICE: Hemotec Whole Blood Control Kit Large (00817869020311)

GUDID

Device Identifier (DI) Information

Brand Name: Hemotec Whole Blood Control Kit Large
Version or Model: SC-125, SC-126, H2O
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANALYTICAL CONTROL SYSTEMS INC

Primary DI Number: 00817869020311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038232682 *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:	Yes
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?
45793	Activated clotting time (ACT) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPA	System, Multipurpose For In Vitro Coagulation Studies

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925340	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc6c0731-21a0-4329-89ae-8e237534f713
Public Version Date: August 01, 2019
Public Version Number: 1
DI Record Publish Date: July 24, 2019