AccessGUDID - DEVICE: KidneyCare Specimen Collection Kit (00860193001747)

GUDID

Device Identifier (DI) Information

Brand Name: KidneyCare Specimen Collection Kit
Version or Model: AS-00005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-00005
Company Name: CAREDX, INC.

Primary DI Number: 00860193001747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102819484 *Terms of Use

Device Description: Convenience mobile phlebotomy sample collection kit

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):	Yes
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?
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8ba872e-7a8f-4dee-89f9-1d93594bd6cc
Public Version Date: November 08, 2022
Public Version Number: 1
DI Record Publish Date: October 31, 2022