FDA UDI
In Commercial Distribution
🇺🇸 United States
Vortek
DI: 05701780333252
·
Model: ACBM57
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Vortek
- Primary DI
- 05701780333252
- Version / Model
- ACBM57
- Catalog Number
- ACBM57
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 1
- Public Version Date
- 2024-04-22
- Public Version Status
- New
- Public Device Record Key
- 94ee9aa7-a703-4797-a8ce-339fe749910d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| FAD | Stent, ureteral | Gastroenterology, Urology | 876.4620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60755 | Urological surgical procedure kit, non-medicated, single-use | A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05701780333276 | GS1 | Shipper Box | 34 | In Commercial Distribution | |
| Package | 05701780333269 | GS1 | Retail Box | 1 | In Commercial Distribution | |
| Primary | 05701780333252 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 22 | Centimeter | |
| Catheter Gauge | 4.8 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.