FDA UDI
In Commercial Distribution
🇺🇸 United States
CoMoveIT
DI: 05430002911069
·
Model: Headset Mounting Clamp
·
Comoveit
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CoMoveIT
- Primary DI
- 05430002911069
- Version / Model
- Headset Mounting Clamp
- Company Name
- Comoveit
- Labeler DUNS
- 372677110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-13
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- af943b5e-16a9-4915-8be1-584950e5583b
Device Description
Mounting clamp for CoMoveIT Smart H3.
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
- Yes
- 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 |
|---|---|---|---|---|
| KNN | Components, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37744 | Wheelchair bracket/mount | A device designed to be attached to a wheelchair to mount a portable accessory (e.g., holder, bag) [not included], as part of wheelchair adaption/customization. It may be in the form of e.g., a rack, adaptor, or clamp. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05430002911069 | GS1 |
Customer Contacts
- Phone
- +32477880175
- [email protected]