FDA UDI
In Commercial Distribution
🇺🇸 United States
GentleCath Hydrophilic
DI: 07333387031750
·
Model: 508997
·
Wellspect AB
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- GentleCath Hydrophilic
- Primary DI
- 07333387031750
- Version / Model
- 508997
- Catalog Number
- 508997
- 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
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 1aba124a-e7ed-4e5c-9478-39fe1517bb10
Device Description
Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 16FR
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EZD | Catheter, straight | 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 | 07333387031774 | GS1 | 4 | In Commercial Distribution | ||
| Package | 07333387031767 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 07333387031750 | GS1 | ||||
| Previous | 00768455142651 | GS1 |
Customer Contacts
- Phone
- +1(800)422-8818
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French | |
| Length | 16 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry