FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Molecular Swab Collection Kit
DI: 00382904439255
·
Model: 443925
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BD Molecular Swab Collection Kit
- Primary DI
- 00382904439255
- Version / Model
- 443925
- Catalog Number
- 443925
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 4
- Public Version Date
- 2025-08-08
- Public Version Status
- Update
- Public Device Record Key
- 6e376d56-8105-4d8b-bfe3-d465291124fe
Device Description
Molecular Swab Collection Kit 100EA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQA | Vaginitis and bacterial vaginosis nucleic acid detection system | Microbiology | 866.3975 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904439255 | GS1 | ||||
| Package | 30382904439256 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201017 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Peel here
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 33 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up