FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 03600040143360
·
Model: AB6022
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 03600040143360
- Version / Model
- AB6022
- Catalog Number
- AB6022
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7f3aedba-3349-4664-876e-a324137214b5
Device Description
X-FLOW® Prostatectomy catheter straight tip 3-way 30-50 ml 100% silicone CH FR 22
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
- 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 |
|---|---|---|---|---|
| EZL | CATHETER, RETENTION TYPE, BALLOON | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32331 | Indwelling urethral drainage/irrigation catheter | A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder where it dwells to provide continuous irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional and may have a bent tip (coude) to facilitate negotiation of the prostatic curve in men. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03600040143377 | GS1 | Retail box | 5 | In Commercial Distribution | |
| Primary | 03600040143360 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013172 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 22 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place