FDA UDI
In Commercial Distribution
🇺🇸 United States
Navina™ Catheter Set Small
DI: 07333387024752
·
Model: 68943
·
Wellspect AB
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Navina™ Catheter Set Small
- Primary DI
- 07333387024752
- Version / Model
- 68943
- Catalog Number
- 6894340
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-01
- Public Version
- 3
- Public Version Date
- 2024-09-24
- Public Version Status
- Update
- Public Device Record Key
- 8eb4583c-7f42-42d5-9ccb-b77fe6144de4
Device Description
Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| FCE | Enema kit | Gastroenterology, Urology | 876.5210 | 1 |
| KNT | Tubes, gastrointestinal (and accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61094 | Rectal irrigation kit | A collection of devices that includes a rectal irrigation nozzle (also known as a catheter) intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. In addition to the disposable nozzle, it includes a reusable fluid container (e.g., water bag). 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 | 07333387025087 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07333387024752 | GS1 | ||||
| Package | 07333387025094 | GS1 | 3 | In Commercial Distribution | ||
| Previous | 07392532243837 | 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.