FDA UDI
In Commercial Distribution
🇺🇸 United States
Penumbra System
DI: 00814548013343
·
Model: IAPS2
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Penumbra System
- Primary DI
- 00814548013343
- Version / Model
- IAPS2
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7dac0823-0ffe-4a2b-ad1c-0f41823e84f3
Device Description
Indigo Pump Max Supplies
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JCX | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41978 | Surgical irrigation/aspiration system | An assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814548013343 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122756 | 000 |