FDA UDI
In Commercial Distribution
🇺🇸 United States
OneCath Hydro
DI: 10810053920036
·
Model: 2031-1614
·
COMPACTCATH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- OneCath Hydro
- Primary DI
- 10810053920036
- Version / Model
- 2031-1614
- Catalog Number
- 2031-1614
- Company Name
- COMPACTCATH, INC.
- Labeler DUNS
- 054765780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2021-10-23
- Public Version
- 1
- Public Version Date
- 2021-11-01
- Public Version Status
- New
- Public Device Record Key
- 11f6d20c-b0d2-4f15-b86b-c0dc071e0fc0
Device Description
The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GBM | Catheter, Urethral | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00810053920039 | GS1 | ||||
| Primary | 10810053920036 | GS1 |
Customer Contacts
- Phone
- +1 (888) 933-2284
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Inch | |
| Catheter Gauge | 14 | French |