FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GP General Purpose Drainage Catheter
DI: H862GPJT1425H0
·
Model: GPJT-1425H
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GP General Purpose Drainage Catheter
- Primary DI
- H862GPJT1425H0
- Version / Model
- GPJT-1425H
- Catalog Number
- GPJT-1425H
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-09
- Public Version
- 2
- Public Version Date
- 2022-05-02
- Public Version Status
- Update
- Public Device Record Key
- 31e5bfb2-35b2-4905-995d-b29044a4f21b
- Distribution End Date
- 2022-04-29
Device Description
HYDROPHILIC COATED GP "J" TIP CATHETER WITH DEPTH MARKS, 14F
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H862GPJT1425H1 | HIBCC | Dispenser | 5 | Not in Commercial Distribution | 2022-04-29 |
| Primary | H862GPJT1425H0 | HIBCC | ||||
| Package | H862GPJT1425H2 | HIBCC | Shipper | 6 | Not in Commercial Distribution | 2022-04-29 |
Customer Contacts
- Phone
- 800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French | |
| Length | 20 | Centimeter |