FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 03600040325148
·
Model: BD4045
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 03600040325148
- Version / Model
- BD4045
- Catalog Number
- BD4045
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 1
- Public Version Date
- 2020-06-29
- Public Version Status
- New
- Public Device Record Key
- e1dc3541-0434-4099-9ec5-57a41ec25f77
Device Description
In-Ka Ureteral Balloon Dilatation Catheter + Inflation device (manometer) Balloon Dilation with inflation device, diameter of the balloon 5 mm, body tube length 75 cm, radiopaque stainless-steel rings + inflation device
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 |
|---|---|---|---|---|
| EZN | DILATOR, CATHETER, URETERAL | Gastroenterology, Urology | 876.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38821 | Endoscopic-access dilator, single-use | A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03600040325148 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Centimeter | |
| Outer Diameter | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place