FDA UDI
In Commercial Distribution
🇺🇸 United States
GentleCath Hydrophilic Kit
DI: 07333387044002
·
Model: 509007
·
Wellspect AB
Product Codes
5
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- GentleCath Hydrophilic Kit
- Primary DI
- 07333387044002
- Version / Model
- 509007
- Catalog Number
- 509007
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-01
- Public Version
- 4
- Public Version Date
- 2024-11-27
- Public Version Status
- Update
- Public Device Record Key
- 70eeb411-cad9-4552-8a11-c82ba984cb2f
Device Description
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 14FR
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYZ | Vinyl patient examination glove | General Hospital | 880.6250 | 1 |
| FAQ | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE | Gastroenterology, Urology | 876.5250 | 1 |
| EZD | Catheter, straight | Gastroenterology, Urology | 876.5130 | 2 |
| EYY | Drape, urological, disposable | General, Plastic Surgery | 878.4370 | 2 |
| NWO | Kit, catheter, urinary (exludes HIV testing) | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45605 | Single-administration urethral catheterization kit, single-use | A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333387044019 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07333387044002 | GS1 | ||||
| Package | 07333387044026 | GS1 | 4 | In Commercial Distribution | ||
| Previous | 00768455142750 | GS1 |
Customer Contacts
- Phone
- +1(800)422-8818
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Catheter Gauge | 14 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry