FDA UDI
In Commercial Distribution
🇺🇸 United States
Invia Motion 60 Days NPWT
DI: 07612367053150
·
Model: 200.8591
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Invia Motion 60 Days NPWT
- Primary DI
- 07612367053150
- Version / Model
- 200.8591
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-22
- Public Version
- 2
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- 4dc40963-3beb-4be9-9dfc-b63c1e1f722e
Device Description
Negative Pressure Wound Therapy Powered Suction Pump - 087.4024
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 20395 | Negative-pressure wound therapy system, electric, reusable | An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07612367053150 | GS1 | ||||
| Direct Marking | 07612367089081 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]