AccessGUDID - DEVICE: Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays (30382904413621)

GUDID

Device Identifier (DI) Information

Brand Name: Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays
Version or Model: 441362
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 441362
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904413621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays

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?
61144	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSL	DNA-REAGENTS, NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081825	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 33 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2bf8dba1-b1db-42f6-86d2-bd106a953ee1
Public Version Date: July 22, 2021
Public Version Number: 5
DI Record Publish Date: May 19, 2016