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

Device Identifier (DI) Information

BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit
440461
In Commercial Distribution
440461
BECTON, DICKINSON AND COMPANY
00382904404611
GS1

1
122561087 *Terms of Use
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
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LSL DNA-REAGENTS, NEISSERIA
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984631 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

989169d4-13b2-4e5d-ac94-fc917789d4f7
July 06, 2018
3
July 13, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30382904404612 100 00382904404611 In Commercial Distribution Shelfpack
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
Technical_services@bd.com
CLOSE