AccessGUDID - DEVICE: BD Vacutainer® Luer-Lok™ Access Device Holder (50382903649025)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® Luer-Lok™ Access Device Holder
Version or Model: 364902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 364902
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382903649025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: BD Vacutainer® Luer-Lok™ Access Device Holder with Pre-Attached Multiple Sample Adapter

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:	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?
60579	Luer-ended blood collection tube spike	A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. 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 [?]
K991088	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: feabf2e6-968b-4ad7-ac21-ea36cf64122c
Public Version Date: October 23, 2019
Public Version Number: 4
DI Record Publish Date: August 22, 2016