AccessGUDID - DEVICE: Kurin Blood Collection Set, 23 Ga, BD Vacutainer (00851682007043)

GUDID

Device Identifier (DI) Information

Brand Name: Kurin Blood Collection Set, 23 Ga, BD Vacutainer
Version or Model: D-11223
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PATHWAY, LLC

Primary DI Number: 00851682007043
Issuing Agency: GS1
Commercial Distribution End Date: July 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 080312381 *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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
58487	Ultrasound-guided intrauterine radio-frequency ablation system	A multicomponent assembly of devices that uses electrical energy in the radio-frequency (RF) band designed to develop heat directly within soft-tissue cells for transcervical and intrauterine ablation of uterine fibroids, and uses ultrasound to target the RF delivery. It consists of a radio-frequency generator, a software-controlled ultrasound system, an intrauterine ultrasound transducer, a monopolar electrosurgical handpiece/electrode, and a return electrode(s). It also typically includes associated cables, and a foot-switch.	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 [?]
Premarket Submission Number Not Available/Not Released

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: 5a31cd14-aa7a-4fad-bf2e-250fc3359370
Public Version Date: August 09, 2019
Public Version Number: 4
DI Record Publish Date: March 13, 2017