FDA UDI
In Commercial Distribution
🇺🇸 United States
Visby Medical Power Adapter, Right Angle
DI: 00810031720071
·
Model: PS-000855
·
Visby Medical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Visby Medical Power Adapter, Right Angle
- Primary DI
- 00810031720071
- Version / Model
- PS-000855
- Catalog Number
- PS-000855
- Company Name
- Visby Medical, Inc.
- Labeler DUNS
- 933894748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-19
- Public Version
- 1
- Public Version Date
- 2023-04-27
- Public Version Status
- New
- Public Device Record Key
- f197f9cf-5464-4e8c-9de2-286121a70945
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | Microbiology | 866.3390 | 2 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | Microbiology | 866.3120 | 1 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Immunology | 866.3860 | 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 | 00810031720071 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200748 | 000 |