AccessGUDID - DEVICE: BD Vacutainer® Sodium Fluoride/Potassium Oxalate 5mg/4mg (30382903679219)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® Sodium Fluoride/Potassium Oxalate 5mg/4mg
Version or Model: 367921
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 367921
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903679219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: BD Vacutainer® Sodium Fluoride Potassium Oxalate 5mg/4mg

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?
47591	Evacuated blood collection tube IVD, anticoagulant/antiglycolytic	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), ammonium oxalate, potassium oxalate, sodium heparin, sodium citrate], and an antiglycolytic agent (e.g., sodium fluoride, lithium iodoacetate). 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 glucose or lactate 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 [?]
K231237	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
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e435a24e-b007-4503-863c-ae6e51bfb6f5
Public Version Date: May 10, 2024
Public Version Number: 7
DI Record Publish Date: August 22, 2016