FDA UDI
In Commercial Distribution
🇺🇸 United States
Docking Station V2C
DI: 00850023837028
·
Model: DSV2C
·
ERESEARCHTECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Docking Station V2C
- Primary DI
- 00850023837028
- Version / Model
- DSV2C
- Company Name
- ERESEARCHTECHNOLOGY, INC.
- Labeler DUNS
- 867288557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-18
- Public Version
- 1
- Public Version Date
- 2021-01-26
- Public Version Status
- New
- Public Device Record Key
- 4608e020-af3f-43c4-a731-0c5faa671f5d
Device Description
Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36252 | Kinesiology ambulatory recorder | A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850023837028 | GS1 |
Customer Contacts
- Phone
- 8007049698
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius