AccessGUDID - DEVICE: Kurin Blood Culture Collection Set (00857606008349)

GUDID

Device Identifier (DI) Information

Brand Name: Kurin Blood Culture Collection Set
Version or Model: MJ-221
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kurin, Inc.

Primary DI Number: 00857606008349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 036018378 *Terms of Use

Device Description: Needle Gauge/Type = 21/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BioMerieux

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:	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?
58497	Blood collection set, invasive	A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162233	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: a1e9ce07-70db-4d12-a3b3-9aabac1a0be2
Public Version Date: July 31, 2023
Public Version Number: 1
DI Record Publish Date: July 21, 2023