AccessGUDID - DEVICE: BD Vacutainer® Blood Transfer Device Holder (50382903648806)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® Blood Transfer Device Holder
Version or Model: 364880
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 364880
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382903648806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: BD Vacutainer® Blood Transfer Device Holder with Pre-Attached Multiple Sample Female Luer 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?
58136	Syringe/blood collection tube adaptor IVD	A dedicated adaptor or transfer device intended to be used to facilitate the transfer of a blood specimen from a syringe into an evacuated blood collection tube. This device is intended to reduce the risk of needle stick injury or exposure to an uncontained blood specimen. 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: f40a3a34-b371-42fd-b9c3-1604111be8d1
Public Version Date: May 06, 2020
Public Version Number: 4
DI Record Publish Date: August 22, 2016