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
440461
In Commercial Distribution
440461
BECTON, DICKINSON AND COMPANY
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
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LSL | DNA-REAGENTS, NEISSERIA |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K984631 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
989169d4-13b2-4e5d-ac94-fc917789d4f7
July 06, 2018
3
July 13, 2016
July 06, 2018
3
July 13, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com