FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 03600040314289
·
Model: ASP285
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 03600040314289
- Version / Model
- ASP285
- Catalog Number
- ASP285
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 94498d51-0a2f-4219-960a-9b6584ee64c4
Device Description
ELEFANT® Suction-irrigation device with connecting tube, diameter 5mm, length 450mm and Elefant® logo on the cannula
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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47342 | Laparoscopic irrigation/aspiration cannula | A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03600040314296 | GS1 | Retail box | 5 | In Commercial Distribution | |
| Primary | 03600040314289 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place