FDA UDI
In Commercial Distribution
🇺🇸 United States
SenSura Xpro
DI: 05708932687379
·
Model: 13638
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SenSura Xpro
- Primary DI
- 05708932687379
- Version / Model
- 13638
- Catalog Number
- 13638
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- 604d5ca5-fa7c-4dca-817c-ea6d2af83aae
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXB | COLLECTOR, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64583 | One-piece urostomy bag, open-ended | A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932687386 | GS1 | Retail Box | 5 | In Commercial Distribution | |
| Primary | 05708932687379 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Base Plate Precut Start Hole Size - mm 10 | ||
| Total Volume | 400 | Milliliter | |
| Device Size Text, specify | Base Plate Max Cut Size - in 2 1/8 | ||
| Device Size Text, specify | Base Plate Max Cut Size - mm 28 | ||
| Device Size Text, specify | Base Plate Precut Start Hole Size - in 3/8 | ||
| Device Size Text, specify | Base Plate Type Flat |