AccessGUDID - DEVICE: BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube (50382903649582)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube
Version or Model: 364958
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 364958
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382903649582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: TUBE URIN PLH 13X75 4.0 C&S KAGN CE

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?
58151	Evacuated urine specimen container IVD, preservative	A covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024240	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4.00 Milliliter

Device Record Status

Public Device Record Key: f43b0cd2-e397-439d-a11b-c4a29eb203cf
Public Version Date: July 22, 2021
Public Version Number: 3
DI Record Publish Date: November 16, 2020