FDA UDI
In Commercial Distribution
🇺🇸 United States
RENASYS GO
DI: 05000223491000
·
Model: 66021496
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RENASYS GO
- Primary DI
- 05000223491000
- Version / Model
- 66021496
- Catalog Number
- 66021496
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 5
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- d02cd60b-be46-4207-abca-3738d50e3294
Device Description
RENASYS GO Device US Only
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
- No
- 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 |
|---|---|---|---|---|
| 47955 | Negative-pressure wound therapy system, battery-powered, reusable | A portable assembly of devices designed to treat hard-to-heal open wounds (e.g., traumatic and chronic) and diabetic/pressure ulcers with suction. It typically consists of a non-sterile battery-powered vacuum pump, an integrated disposable collection canister, and a shoulder bag for carrying during ambulation. It is connected to the patient with drainage tubing. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05000223491000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152163 | 000 |