FDA UDI
In Commercial Distribution
🇺🇸 United States
VascuChek Speaker Dock
DI: 00813079022671
·
Model: VC-SD-01
·
REMINGTON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VascuChek Speaker Dock
- Primary DI
- 00813079022671
- Version / Model
- VC-SD-01
- Catalog Number
- VC-SD-01
- Company Name
- REMINGTON MEDICAL, INC.
- Labeler DUNS
- 788472314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-27
- Public Version
- 1
- Public Version Date
- 2025-12-05
- Public Version Status
- New
- Public Device Record Key
- bae6b307-78b9-438f-ab8c-f6b957778e81
Device Description
Speaker Dock is connected to Transciever via bluetooth
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60451 | Laser Doppler blood flowmeter | A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813079022671 | GS1 |
Customer Contacts
- Phone
- +017708888520
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251904 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 136 | Millimeter |