FDA UDI
In Commercial Distribution
🇺🇸 United States
Dr.INVIVO
DI: 08809692500285
·
Model: 4D2D101
·
ROKIT HEALTHCARE Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dr.INVIVO
- Primary DI
- 08809692500285
- Version / Model
- 4D2D101
- Company Name
- ROKIT HEALTHCARE Inc.
- Labeler DUNS
- 689004656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-02
- Public Version
- 1
- Public Version Date
- 2026-04-10
- Public Version Status
- New
- Public Device Record Key
- 57690fd3-721c-482f-9328-b36c6c2a323f
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 |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41663 | Laboratory liquid dispenser, electronic | An electronic laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The intended volume is normally user-selected prior to the delivery of the liquid. The device typically has a peristaltic pump for delivery of the preselected volume that typically ranges from 1 ml to 9.99 L. This device can be user operated, automatic, or programmable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809692500282 | GS1 | Carton Box | 1 | In Commercial Distribution | |
| Primary | 08809692500285 | GS1 |