FDA UDI
In Commercial Distribution
🇺🇸 United States
Navina™ Classic System Refill
DI: 07333387052601
·
Model: 69106
·
Wellspect AB
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Navina™ Classic System Refill
- Primary DI
- 07333387052601
- Version / Model
- 69106
- Catalog Number
- 6910640
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-10
- Public Version
- 1
- Public Version Date
- 2025-01-20
- Public Version Status
- New
- Public Device Record Key
- 6714d4f3-dead-4d8c-914c-135a5b6bb240
Device Description
Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, Non Sterile Device. Rx Only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
| FCE | Enema kit | Gastroenterology, Urology | 876.5210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45510 | Manual rectal irrigation system | A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal nozzle/catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333387052618 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 07333387052601 | GS1 |
Customer Contacts
- Phone
- +1(877)456-3742
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place at room temperature.