AccessGUDID - DEVICE: BD Vacutainer® SST™ II Advance (50382903664448)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® SST™ II Advance
Version or Model: 366444
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 366444
Company Name: Becton, Dickinson U.K. Limited

Primary DI Number: 50382903664448
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1000
Labeler D-U-N-S® Number*: 225931062 *Terms of Use

Device Description: BD Vacutainer® SST™ II Advance

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?
41128	Evacuated blood collection tube IVD, clot activator/separator	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). 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 [?]
BK050036	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: 10c3d601-1cc1-4501-8489-e45cb4d0d84a
Public Version Date: April 12, 2023
Public Version Number: 5
DI Record Publish Date: July 28, 2016