FDA UDI
In Commercial Distribution
🇺🇸 United States
Navina™ Classic Control Unit
DI: 07333387028330
·
Model: 69013
·
Wellspect AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Navina™ Classic Control Unit
- Primary DI
- 07333387028330
- Version / Model
- 69013
- Catalog Number
- 6901340
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-25
- Public Version
- 2
- Public Version Date
- 2023-10-06
- Public Version Status
- Update
- Public Device Record Key
- 1d0c8a7b-e718-4e7f-9e9a-2fd5aa41e05f
Device Description
Navina Classic Transanal Irrigation. 1 Navina Classic control unit. Non Sterile Device. Rx Only.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, gastrointestinal (and accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61113 | Powered rectal irrigation system control unit | A portable, battery-powered regulator that is a component of a rectal irrigation system and designed to create the pressure required to propel the irrigation water into the rectum. It includes a pump and regulating device (e.g., a valve) intended to control the air/water balance of the system. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence; it is not intended for irrigation of the entire colon. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333387028347 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 07333387028330 | GS1 | ||||
| Previous | 07392532198526 | GS1 |
Customer Contacts
- Phone
- +1(877)456-3742
- [email protected]