AccessGUDID - DEVICE: Resolution ctDx FIRST Sample Collection Kit (00850059806005)

GUDID

Device Identifier (DI) Information

Brand Name: Resolution ctDx FIRST Sample Collection Kit
Version or Model: 500029
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Resolution Bioscience, Inc.

Primary DI Number: 00850059806005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079831618 *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):	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?
66838	Venous blood collection kit IVD	A collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous access needle with tubing and connector, a blood collection tube(s) [with or without additives (e.g., sodium citrate)], and additional items (e.g., tourniquet, pipette, gauze pads, alcohol pads, dressings and a container with a requisition form, for mailing to the laboratory). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQP	Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P210040	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: 07e2a3e8-0b6a-4e88-b957-38bdf45c346b
Public Version Date: April 08, 2024
Public Version Number: 1
DI Record Publish Date: March 31, 2024