AccessGUDID - DEVICE: Serim® GUARDIAN™ Blood Leak Test Strips (M1745119C)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® GUARDIAN™ Blood Leak Test Strips
Version or Model: 5119C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5119C
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M1745119C
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.

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?
32128	Haemodialysis system blood leak detector	An electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJD	Detector, Leak, Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012115	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 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7eed404-9689-42d2-8b91-682f75550c0d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 12, 2017