FDA UDI
In Commercial Distribution
🇺🇸 United States
32nd Street Media
DI: 00860011846406
·
Model: TMB-2284-B
·
Nicole Anderson Media Services, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 32nd Street Media
- Primary DI
- 00860011846406
- Version / Model
- TMB-2284-B
- Company Name
- Nicole Anderson Media Services, LLC
- Labeler DUNS
- 078733061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 3
- Public Version Date
- 2025-09-10
- Public Version Status
- Update
- Public Device Record Key
- 91dc19cd-6398-4d38-b6ff-ab478b4d8558
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62279 | Blood pressure cuff inflation regulator | A mains-electricity (AC-powered) device intended to interface between an air compressor and a vascular cuff to regulate rapid inflation of the cuff during procedures to assess vascular health (e.g., venous insufficiency, maximum venous outflow, arterial inflow). Intended to be used by a healthcare professional in a clinical setting, it consists of a compact unit with display/controls, pressure regulator, and tubing to connect to the cuff. It is intended to regulate inflation to a preselected target pressure, to maintain that pressure, and subsequently deflate the cuff; it may be intended to be used with a timer for automatically-triggered inflation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011846406 | GS1 |