FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 05705243322173
·
Model: E80203
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 05705243322173
- Version / Model
- E80203
- Catalog Number
- E80203
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-20
- Public Version
- 1
- Public Version Date
- 2019-04-29
- Public Version Status
- New
- Public Device Record Key
- 984ed4a8-4aaf-4905-9a59-c37c613554b0
Device Description
EASIVAC® / System for collecting pieces of tissue after TURP / Connector - STORZ
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 |
|---|---|---|---|---|
| FFD | EVACUATOR, BLADDER, MANUALLY OPERATED | Gastroenterology, Urology | 876.4370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11301 | Closed-wound/centesis drainage receptacle | A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932648462 | GS1 | Retail box | 20 | In Commercial Distribution | |
| Primary | 05705243322173 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place