FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Affirm™ Affirm VPIII Sample Collection Sets
DI: 00382904462505
·
Model: 446250
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Affirm™ Affirm VPIII Sample Collection Sets
- Primary DI
- 00382904462505
- Version / Model
- 446250
- Catalog Number
- 446250
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 3
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- b6c664ad-52b8-4fe0-9c5c-c06cee8d568b
Device Description
BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sample Collection Tube, Sample Collection Tube Cap
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| LIO | Device, specimen collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48208 | Multiple-type vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of organisms associated with vaginitis in a clinical specimen, using a nucleic acid technique (NAT). Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904462505 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920536 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius