FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO-Diary
DI: B329PDV25
·
Model: PDV
·
CAMNTECH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PRO-Diary
- Primary DI
- B329PDV25
- Version / Model
- PDV
- Catalog Number
- 05-121
- Company Name
- CAMNTECH LIMITED
- Labeler DUNS
- 399114941
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-29
- Public Version
- 2
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 241ff69c-ff87-4639-9328-042770dea041
Device Description
Ambulatory Physical Activity Recorder with Electronic Patient diary
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
- 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 |
|---|---|---|---|---|
| LEL | Device, Sleep Assessment | Neurology | 882.5050 | 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 | B329PDV25 | HIBCC |
Customer Contacts
- Phone
- +1 830-755-8036
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132764 | 000 |