AccessGUDID - DEVICE: BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit (00382904404611)

GUDID

Device Identifier (DI) Information

Brand Name: BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit
Version or Model: 440461
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 440461
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904404611
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit Contains: 100 each rayon-tipped swab

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Absorbent tipped applicator, sterile	A device intended for medical purposes which include, to apply medications to, or to take specimens from, a patient or an object. It is typically designed as an absorbent, sterile, swab on a wooden, paper, or plastic stick. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
LSL	DNA-REAGENTS, NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984631	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 989169d4-13b2-4e5d-ac94-fc917789d4f7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 13, 2016